Alzheimer's Disease Ongoing Trials 2013...Alzheimer's-Disease-Cooperative-Study-Activities-of Daily-Living-Inventory prospective drug vs drug + nondrug comparison Assessment scale

Endpoint Resultmulticentre Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

open Alzheimer's Disease Assessment Scale cognitive

subpart

Alzheimer's-Disease-Assessment-Scale

prospective Assessment scale scores Cognitive-function

Clinical Global Impressions scale

Cognitive function

Disability Assessment for Dementia

Medication Satisfaction Questionnaire

Mini Mental State Examination

Quality of life

multicentre Alzheimer's Disease Assessment Scale cognitive

subpart

open Mini Mental State Examination

prospective Treatment discontinuation

Donepezil multicentre control group comparison Alzheimer's Disease Assessment Scale Western-Aphasia-Battery

Memantine open drug combination comparison Mini Mental State Examination

parallel Neuropsychiatric Inventory

prospective Severe Impairment Battery

randomised Western Aphasia Battery

double-blind baseline comparison Apolipoprotein ratios Cerebral-blood-flow

multicentre patient comparison Cerebral blood flow

parallel placebo comparison Cognitive function tests

randomised Gene expression

multicentre Cognitive function Skin-parameters

observational Skin parameters

open Treatment discontinuation

prospective

open Mini Mental State Examination Mini-Mental-State-Examination

prospective Unified Parkinson's Disease Rating Scale Unified-Parkinson's-Disease-Rating-Scale

multicentre Instrumental Activities of Daily Living Scale Instrumental-Activities-of-Daily-Living-Scale

observational Patient compliance

open

parallel

prospective

open Amyloid levels Amyloid-levels

randomised Cerebrovascular function parameters Cognitive-function-tests

Cognitive function tests

Haemodynamic parameters

cohort baseline comparison Assessment scale scores

observational subject comparison Clinical response

open Magnetic resonance imaging outcomes

prospective

10

Behaviour and cognition in Alzheimer s disease

patients treated with the NMDA receptor

antagonist memantine collelation with the

apoptotic mechanisms.

Memantine IV Recruiting prospective Clinical response 03 Mar 2006 (actual) 03 Mar 2010 (planned) 700199058 (Clinical Trials Insight),

EudraCT2005-004498-31 (European

Clinical Trials Database), SC05-02

(Fondazione Santa Lucia)

double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Computerised-tomography-changes

parallel placebo comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryprospective Caregiver assessment

randomised Clinical Dementia Rating

Computerised tomography changes


Neuropsychiatric Inventory

Donepezil multicentre baseline comparison Neuropsychiatric Inventory Patient-compliance

Galantamine open drug comparison Patient assessment Treatment-discontinuation

Rivastigmine randomised Patient compliance

Treatment discontinuation

Donepezil double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

FPF-1070 multicentre drug comparison Clinician's Interview Based Impression of Change

Plus

Clinician's-Interview-Based-Impression-of-Change-Plus

parallel Treatment discontinuation Treatment-discontinuation

prospective

randomised

cohort Cost

observational Resource use

prospective

double-blind baseline comparison Clinical response

open duration of treatment comparison Disease progression

parallel placebo comparison Magnetic resonance imaging outcomes

prospective

randomised

case control control group comparison Biomarker levels Disease-progression-rate

retrospective subject comparison Brain volume Memory-Performance-Index

Disease progression rate

Functional Assessment Staging scale

Memory Performance Index

Trail Making Test Part A

Trail Making Test Part B

open Neuropsychiatric Inventory Zarit-Burden-Interview

prospective Zarit Burden Interview

open baseline comparison Clinical Dementia Rating Mini-Mental-State-Examination

parallel patient comparison Mini Mental State Examination

prospective

multicentre Alzheimer's Disease Assessment Scale cognitive

subpart


open Clinical Global Impressions scale

prospective Clinical response rate

multicentre control group comparison 10 meter walk test Berg-Balance-Scale

open nondrug vs nondrug comparison Apathy Inventory Quality-of-life-utility

parallel Berg Balance Scale

prospective Cost

randomised Distance walked



Quality of life utility



double-blind baseline comparison Assessment scale scores Proportion-of-glycosylated-haemoglobin

multicentre placebo comparison Clinical Global Impressions scale

parallel Instrumental Activities of Daily Living Scale

randomised Proportion of glycosylated haemoglobin

Alzheimer's Disease Ongoing Trials 2013

01 Jan 2009 (actual) 01 Jan 2011 (planned)

21

Improving Function, Quality of Life, Glycemia in

Diabetics With Dementia.

Methylphenidate 470-08FB, 700039289 (Clinical Trials

Insight), 91992, NCT00792662

(ClinicalTrials.gov: US National

Institutes of Health)

IV Recruiting

Recruiting 01 Oct 2011 (actual) 01 Sep 2013 (planned)

20

Health Related Quality of Life Effects of Off-the-

shelf Computer Gaming in Alzheimer and Related

Disorders Populations.

11PP06, 700204640 (Clinical Trials

Insight), NCT01416012



IV

IV Active, no longer recruiting baseline comparison 01 Sep 2011 (actual) 01 Dec 2013 (planned) Janssen Pharmaceutical KK

IV Not yet recruiting 01 May 2013 (planned)

19

Evaluation of Efficacy and Safety of Galantamine

in Subjects With Dementia of Alzheimer's Type

Who Failed to Benefit From Donepezil.

Galantamine 700210104 (Clinical Trials Insight),

CR018649 (Johnson and Johnson),

JNS023JPN02 (Janssen Pharmaceutical

KK), NCT01478633 (ClinicalTrials.gov:

US National Institutes of Health)

Recruiting baseline comparison 05 Feb 2013 (actual)

18

Efficacy of donepezil in Alzheimer's disease

combined with cerebrovascular disease

Donepezil 700231384 (Clinical Trials Insight),

UMIN000010408 (University Hospital

Medical Information Network - Japan)

17Effectiveness of Galantamine on the care burden

of family caregivers of patients with Alzheimer's

disease




IV

IV Recruiting 01 Dec 2012 (actual) 01 Mar 2014 (planned) Pamlab

01 Sep 2008 (planned)

16

Effect of Cerefolin/CerefolinNAC on Biomarker

Measurements in Patients With Mild Cognitive

Impairment, Alzheimer's Disease and Related

Disorders

Acetylcysteine/mecobalami

n/methylfolate

700227154 (Clinical Trials Insight),

NAC002c (Pamlab), NCT01745198



Eli Lilly

15

Diffusion tensor weighted MRI [magnetic

resonance imaging] in Alzheimer's disease:

Prediction and mapping of symptomatic and

disease modifying treatment effects of

galantamine (Reminyl)


DTI001, EudraCT2005-003762-41

(European Clinical Trials Database),

NCT00523666 (ClinicalTrials.gov: US

National Institutes of Health)

IV Recruiting 01 Sep 2006 (actual)

Active, no longer recruiting

14

Costs and Resource Use of Alzheimers Disease in

Europe (GERAS).

6927 (United Kingdom Clinical

Research Network), 700060587

(Clinical Trials Insight), DeNDRoN045

(Dementias and Neurodegenerative

Diseases Research Network)

IV

01 Sep 2013 (planned) 01 Dec 2016 (planned) EVER Neuro Pharma

13

Comparison of Cerebrolysin and Donepezil: A

Randomized, Double-blind, Controlled Trial on

Efficacy and Safety in Patients With Mild to

Moderate Alzheimer's Disease



Clinical Trials Database), EVE-AT0412

(EVER Neuro Pharma), NCT01822951



IV Not yet recruiting

01 Apr 2011 (actual) 01 Sep 2013 (planned)

Recruiting 01 May 2010 (actual) 01 Dec 2011 (planned) Korea Otsuka Pharmaceutical

12

Comparative Effectiveness Research Trial of

Alzheimer's Disease Drugs.




IV Recruiting

11

Cilostazol Augmentation Study In Dementia

(CASID): A Randomized, Placebo-controlled Pilot

Study to Compare the Efficacy Between

Donepezil Monotherapy and Cilostazol

Augmentation Therapy in Alzheimer's Disease

Patients With Subcortical White Matter

Hyperintensities

Cilostazol 06-2009-145, 700204310 (Clinical

Trials Insight), NCT01409564



IV

Recruiting 31 May 2015 (planned)

9

Auditory attention in the amnesia of Alzheimer's

Disease and the response to a central

cholinesterase inhibitor.

Cholinesterase-inhibitors 11776 (United Kingdom Clinical


(Clinical Trials Insight)

IV

Recruiting control group comparison 29 Jun 2006 (actual) 29 Jun 2008 (planned)

8

An open label evaluation of the safety and

efficacy of nilvadipine in mild to moderate

Alzheimer's Disease.

Nilvadipine 700200609 (Clinical Trials Insight),


Clinical Trials Database), RK100-1

(Roskamp Institute)

IV

IV Recruiting baseline comparison 20 Feb 2013 (actual) 31 Oct 2014 (planned) Nutricia

Recruiting baseline comparison 17 May 2013 (actual) 16 May 2015 (planned)

7

An observational study to evaluate the use of

Souvenaid in real world daily clinical practice in

patients with early Alzheimer's Disease.

Nutrient-formulae 14376 (Netherlands Trial Register

Candidate Number), 700229856

(Clinical Trials Insight),

IRBN2012014HdJ1, NTR3855

(Netherlands Trial Register)

6

A study on usefulness and safety of donepezil for

cognitive function and phychological symptoms

of patients with Parkinson's disease and

Alzheimer type dementia.




IV

IV Recruiting baseline comparison 01 Jun 2009 (actual) 01 Jul 2011 (planned)

IV Recruiting 01 Oct 2010 (actual) 01 Dec 2011 (planned)

5

A Six-month, Open Labeled, Multi-centered,

Observational Study for the Tolerability of Exelon

Patch (Rivastigmine) for Patients With


Rivastigmine 700196025 (Clinical Trials Insight),


National Institutes of Health), X-MEN

(Seoul National University Hospital)

01 Mar 2015 (planned)

4

A Single-site Positron Emission Tomography

(PET) Study of the Cerebral Metabolic Effects of

AC-1202 (Axona) Treatment in Mild-to-Moderate

Alzheimer's Disease (AD).

AC-1202 700056227 (Clinical Trials Insight), GG-

AC1202, NCT01122329



01 Aug 2012 (actual) 01 Dec 2014 (planned) Novartis

3

A Multicenter, Randomized, Open-label,

Prospective Study to Estimate the add-on Effects

of Memantine as Ebixa Oral Pump on Language in

Moderate to Severe Alzheimer's Disease Patients

Already Receiving Donepezil.

14394A (Konkuk University Medical

Center), 700232825 (Clinical Trials




IV Recruiting 01 Jan 2013 (actual)

2

A 52-week, Prospective, Multi-center, Open-label

Study to Assess the Tolerability of Rivastigmine

Before and After Switching From Oral

Formulation to Transdermal Patch in Patients

With Alzheimer's Dementia in a Controlled

Titration Schedule


CENA713DTW04 (Novartis),



IV Recruiting baseline comparison


CENA713D1403 (Novartis),



IV

Study Phase Study Status Study Design Study Controls Study EndpointOfficial Study Title Drug(s) Study ID

Recruiting baseline comparison 01 Mar 2012 (actual) 01 Nov 2013 (planned) Novartis, Ono Pharmaceutical

Primary EndpointsStart Date End Date Company

1

A 24-week, Open-label, Multicenter Study to

Evaluate the Efficacy, Safety and Tolerability of

Rivastigmine Patch in Patients With Mild to

Moderate Alzheimer's Disease (MMSE 10-23)

Switched From Cholinesterase Inhibitors

(Donepezil, Galantamine).

Rivastigmine

Acetylcholinesterase-

inhibitors

multicentre Drug-utilisation

Memantine prospective

Brain derived neurotrophic factor levels Brain-derived-neurotrophic-factor-levels

Clinical response Clinical-response

Cytokine levels Cytokine-levels

Inflammatory markers Inflammatory-markers

Laboratory parameters

Neurological parameters

Treatment failure

Mini Mental State Examination Mini-Mental-State-Examination

Neuropsychiatric Inventory Neuropsychiatric-Inventory

Polysomnographic measures Polysomnographic-measures

Antidementias baseline comparison Motor-function

Vitamin-D-analogues patient comparison

parallel baseline comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventory

Alzheimer's-Disease-Cooperative-Study-Activities-of-

Daily-Living-Inventory

prospective drug vs drug + nondrug comparison Assessment scale scores Clinician's-Interview-Based-Impression-of-Change-Plus

randomised Behavioural Pathology in Alzheimer's Disease

Rating Scalesingle-blind Clinician's Interview Based Impression of Change

PlusGlobal Deterioration Scale


Severe Impairment Battery

Haloperidol double-blind baseline comparison Abnormal Involuntary Movement Scale Bristol-Activities-of-Daily-Living-Scale

Memantine multicentre drug comparison Bristol Activities of Daily Living Scale Cohen-Mansfield-Agitation-Inventory

Olanzapine parallel Clinical Global Impressions scale

Quetiapine prospective Cognitive function tests

Risperidone randomised Cohen Mansfield Agitation Inventory




Unified Parkinson's Disease Rating Scale

Abnormal Involuntary Movement Scale Abnormal-Involuntary-Movement-Scale

Barnes Akathisia Scale Barnes-Akathisia-Scale

Cognitive function tests Cognitive-function-tests

Medical Outcome Study Short Form 36 Medical-Outcome-Study-Short-Form-36

Neuropsychiatric Inventory Neuropsychiatric-Inventory

Simpson Angus scale Simpson-Angus-scale

double-blind baseline comparison Amyloid levels Hopkins-Verbal-Learning-Test

parallel placebo comparison Hopkins Verbal Learning Test

prospective

randomised

cohort Alzheimer's-Disease-Assessment-Scale

observational

postmarketing surveillance

prospective

cohort Assessment scale scores Clinical-response

multicentre Clinical response Mini-Mental-State-Examination

observational Cognitive function tests

postmarketing surveillance Mini Mental State Examination

prospective


subpart


prospective Cerebral blood flow Cerebral-blood-flow

Mini Mental State Examination Mini-Mental-State-Examination

open baseline comparison Clinical response Pharmacokinetic-parameters

prospective patient comparison Cognitive function tests Receptor-occupancy

subject comparison Pharmacokinetic parameters

untreated control group comparison Receptor occupancy

Response

Symptoms

observational Activities of Daily Living Scale Physician-assessment

retrospective Additional treatment required treatment

conversionPatient assessment

Physician assessment


prospective Neuropsychiatric Inventory

crossover baseline comparison Cerebral blood flow Cerebral-blood-flow

double-blind placebo comparison Cognitive function tests

prospective Letter and Category Fluency

randomised Mini Mental State Examination



Cognitive function Motor-function

Motor function


subpart


parallel placebo comparison Assessment of Quality of Life Cognitive-function-tests

prospective Cognitive function tests Mini-Mental-State-Examination


Quality of Life Index

Visual Analogue Scale

double-blind Assessment scale scores

randomised Clinical response rate

Complete clinical response rate

Hamilton Depression Rating Scale

Improvement in symptoms


Partial clinical response rate

Donepezil open baseline comparison Alzheimer's Disease Cooperative Study Activities


Assessment-scale-scores

Memantine parallel drug combination comparison Assessment scale scores Mini-Mental-State-Examination

prospective drug regimen comparison Mini Mental State Examination Severe-Impairment-Battery

randomised Neuropsychiatric Inventory


01 Sep 2011 (planned)

40

The effect of combination therapy of Donepezil

and Memary for moderate to severe Alzheimer's

disease




IV Not yet recruiting

Active, no longer recruiting placebo comparison

39

The Depression in Alzheimer's Disease Study

(DIADS)

Sertraline 700005197 (Clinical Trials Insight),

IA0010 (National Institute on Aging),



IV

Not yet recruiting 15 Aug 2012 (planned)

38

The chronic effects of Bacopa on cognitive

performance in Alzheimer's patients - A pilot

study

Bacopa-monnieri 362754 (Australian New Zealand

Clinical Trials Registry Request

Number), 700221353 (Clinical Trials

Insight), ACTRN12612000785808

(Australian New Zealand Clinical Trials

Registry)

IV

Recruiting prospective baseline comparison 11 Jan 2012 (actual) 01 Jan 2014 (planned)

37

The ACER-study - the effects of galantamine on

the variability and stability of walking among

patients with Alzheimer's disease. De ACER-

studie - effecten van galantamine op de

variabiliteit en stabiliteit van het looppatroon bij

patienten met de ziekte van Alzheimer.



Clinical Trials Database), NL38747-048-

11 (Centrale Commissie Mensgebonden

Onderzoek)

IV

2011P000303 (Beth Israel Deaconess

Medical Center), 700215093 (Clinical




IV

IV Not yet recruiting baseline comparison 01 Oct 2012 (planned)

Recruiting baseline comparison 01 Jan 2012 (actual) 01 May 2012 (planned) Accera

35

Safety and Efficacy analysis of 10 mg donepezil

for severe Alzheimer's disease: switch from the

other cholineseterase inhibitors




34

Retrospective Cohort Study Of The Efficacy Of

Axona (Medium Chain Triglycerides) In Patients

With Alzheimer's Disease.

AC-1202 700214086 (Clinical Trials Insight),

AX11-009, NCT01538212



IV

Recruiting baseline comparison 01 Apr 2012 (actual) Janssen Pharmaceutical KK

33

Rationalisation of Antipsychotic Drug Use in Older

People, Using [18F]-Fallypride PET

Amisulpride

Recruiting 01 Feb 2012 (actual) 01 Jul 2013 (planned)

36

Seizure-like Hippocampal Activity in Alzheimer's

Disease Neurodegeneration

Levetiracetam

11SC0486 (Multicentre Research Ethics

Committee (MREC)), 12780 (United

Kingdom Clinical Research Network),

2167SR (Suzanne Reeves, Institute of

Psychiatry, London), 700208644

(Clinical Trials Insight), EudraCT2011-

005218-13 (European Clinical Trials

Database), NCT01454453



32

Prediction of symptomatic response to

galantamine treatment by regional cerebral blood

flow measurement in Alzheimer's disease

patients.




IV

01 Jun 2010 (actual) 01 Dec 2015 (planned) Eisai Co Ltd, Eisai Inc

Eisai Co Ltd, Eisai Inc

31

Post-marketing Surveillance of Long-term

Administration of Donepezil Hydrochloride -

Investigation of the Clinical Condition and Safety

in Patients With Alzheimer's Disease


ART05T, NCT01129596



IV Active, no longer recruiting baseline comparison

IV Active, no longer recruiting baseline comparison Alzheimer's Disease Assessment Scale 01 Oct 2010 (actual) 01 Sep 2016 (planned)

IV Recruiting 23 Apr 2012 (actual) 31 Mar 2016 (planned)

IV Recruiting 01 Jun 2011 (actual) 01 Apr 2014 (planned)

30

Post-marketing Surveillance of Donepezil

Hydrochloride- Investigation of the Clinical Safety

and Effectiveness in Patients With Alzheimer's

Disease


ART06T (Eisai Co Ltd), NCT01251718



placebo comparison Johnson & Johnson

29

Pilot Trial of Carvedilol in Alzheimer's Disease Carvedilol 700198756 (Clinical Trials Insight),



28

Phase IV study of General Clinical Research

Center of the Jinan Mental Hospital (Taiwan)

Risperidone 700031751 (Clinical Trials Insight),


National Institutes of Health), REM-

TWN-MA5

IV Active, no longer recruiting double-blind

01 Apr 2008 (actual) 10 Jun 2011 (planned) Lundbeck A/S

27

Memantine for the Long Term Management of

Neuropsychiatric Symptoms in Alzheimer's

disease (MAIN-AD).

08MRE09-5 (Multicentre Research

Ethics Committee (MREC)), 5624

(United Kingdom Clinical Research

Network), 68407918 (ISRCTN: Current

Controlled Trials), 700030955 (Clinical

Trials Insight), EudraCT2007-004897-

26 (European Clinical Trials Database),

Lu11829A (King's College London)

IV Active, no longer recruiting

Active, no longer recruiting 01 Aug 2006 (actual) 01 Dec 2013 (planned) Forest Laboratories

26

Memantine and Comprehensive, Individualized,

Patient Centered Management of Alzheimer's

Disease: A Randomized Controlled Trial.

Memantine 700045104 (Clinical Trials Insight),

H12444-01A, NAM-MD18 (Forest

Laboratories), NCT00120874



IV

prospective Motor function 01 Nov 2009 (actual) 01 Nov 2017 (planned)

25

Maladie d'Alzheimer et Maladies apparentees :

Caracterisation Des Anomalies Cognitivo-

motrices, et Des Effets Des medicaments Anti-

demence et de la Vitamine D a Partir de la Mise

en Place d'Une Base de donnees au CMRR du

CHU d'Angers

2009-150, 700196241 (Clinical Trials




IV Recruiting

Recruiting observational baseline comparison 01 Sep 2011 (actual)

24

Investigation on the effects of memantine on

psychiatric symptoms and sleep disturbances in

patients with Alzheimer's disease




IV

IV Recruiting prospective baseline comparison 02 Feb 2010 (actual) 02 Oct 2011 (planned)

Drug utilisation 01 Jan 2009 (actual) 01 Jan 2011 (planned)

23

Investigating the neuroprotective effect of

Donepezil in patients affected by Alzheimer

disease: a 12 month longitudinal analysis of the

peripheral levels of neurotrophins and

inflammatory factors in first-diagnosis patients




(FONDAZIONE SANTA LUCIA)

22

Inappropriate Medications and Alzheimer

Disease: Prevalence and Associated Factors in

Elderly Patients Treated With Anticholinesterase

and/or Memantine. MIDA Study.


I07033 (University Hospital Limoges),



IV Recruiting

Donepezil prospective drug combination comparison Clinical response Drug-concentration

Rivastigmine single-blind drug comparison Drug concentration

patient comparison

cohort Drug-utilisation

prospective

double-blind baseline comparison Alzheimer's Disease Assessment Scale Apathy-Evaluation-Scale

multicentre placebo comparison Alzheimer's Disease Assessment Scale cognitive

subpartparallel Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryprospective Apathy Evaluation Scale

randomised Caregiver assessment




Quality of life

Quality of life instrument

Resource use


subpart

Treatment-discontinuation

multicentre regimen comparison Clinical Global Impressions scale

parallel Mini Mental State Examination

prospective Treatment completion rate

randomised Treatment discontinuation

double-blind baseline comparison Clinician's Interview Based Impression of Change

Plus

Severe-Impairment-Battery

multicentre placebo comparison Severe Impairment Battery

parallel

prospective

randomised

Donepezil double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

SK-PC-B70M parallel drug comparison Clinical Dementia Rating

prospective drug dosage comparison Clinician's Interview Based Impression of Change

Plusrandomised placebo comparison Mini Mental State Examination


subpart


multicentre patient comparison Amyloid levels

parallel placebo comparison Biomarker levels

prospective Clinical Dementia Rating

randomised Disability Assessment for Dementia

Inflammatory markers

Tau levels

double-blind baseline comparison Alzheimer's Disease Assessment Scale Assessment-scale-scores

multicentre placebo comparison Assessment scale scores Clinical-Global-Impressions-scale

parallel Clinical Global Impressions scale


randomised


subpart


Galantamine multicentre drug combination comparison Alzheimer's Disease Cooperative Study Activities




Masitinib parallel drug dosage comparison Bodyweight

Memantine prospective placebo comparison Clinical Dementia Rating

Rivastigmine randomised Clinical response rate

ECG changes




Pulse rate

Resource use

Urinalysis

Vital signs

double-blind baseline comparison Clinical Global Impressions scale Cohen-Mansfield-Agitation-Inventory

multicentre drug dosage comparison Cohen Mansfield Agitation Inventory

parallel placebo comparison Neuropsychiatric Inventory

prospective

randomised

double-blind patient comparison Alzheimer's Disease Assessment Scale


subpartprospective Cognitive function tests

Insulin levels

Doxycycline baseline comparison Cytokine levels Cytokine-levels

Rifampicin drug combination comparison Inflammatory markers Interleukin-10-levels

drug comparison Interleukin 10 levels Interleukin-4-levels

placebo comparison Interleukin 4 levels Monocyte-chemoattractant-protein-1-levels

subject comparison Monocyte chemoattractant protein 1 levels Tumour-necrosis-factor-alpha-levels

Tumour necrosis factor alpha levels

double-blind

multicentre

parallel

prospective

randomised

double-blind drug dosage comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

multicentre placebo comparison Alzheimer's Disease Cooperative Study Activities




randomised Clinical Global Impressions scale Clinician's-Interview-Based-Impression-of-Change-Plus

Clinician's Interview Based Impression of Change

Plus

Neuropsychiatric-Inventory


Cholinesterase-inhibitors open Cerebral blood flow Cerebral-blood-flow

Memantine prospective Cognitive function Cognitive-function

Computed tomography Computed-tomography

Magnetic resonance imaging outcomes Magnetic-resonance-imaging-outcomes

Methylthioninium-chloride double-blind baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale

Methylthioninium-chloride- multicentre drug dosage comparison Alzheimer's Disease Assessment Scale

parallel placebo comparison Alzheimer's Disease Cooperative Study Clinical

Global Impression of Changerandomised Cerebral blood flow

Clinical Dementia Rating



Magnetic resonance imaging outcomes



Symptoms

01 Aug 2004 (actual) 01 Sep 2007 (planned) TauRx Therapeutics

56

An exploratory placebo controlled, dose ranging

study of the effects of TRx0014

[methylthioninium chloride] 30mg tid, 60mg tid

and 100mg tid in patients with mild to moderate

dementia of the Alzheimer type

04S0801-1 (Multicentre Research


(Clinical Trials Insight), N0222149768

(National Research Register: National

Health Service), N0281162153

(National Research Register: National

Health Service), NCT00515333


Institutes of Health), TRx014-001

(TauRx Therapeutics)

III Active, no longer recruiting

Raptor Pharmaceutical Corp

55

A study on the effect of memantine for

psychological symptoms and cerebral blood flow

of patients with Alzheimer's disease.




III Not yet recruiting drug combination comparison 03 Jun 2013 (planned)

Adamas Pharmaceuticals

54

A randomised, double-blind, placebo-controlled

study to evaluate the safety and efficacy of two

different doses of phenserine-tartrate in patients

with probable mild to moderate Alzheimer's

disease.

Phenserine 700199177 (Clinical Trials Insight), AX-

CL10 (Axonyx), EudraCT2004-000933-

12 (European Clinical Trials Database)

III Recruiting 23 Sep 2004 (actual) 23 Dec 2005 (planned)

Planning baseline comparison 01 Dec 2012 (planned)

53

A pivotal phase III trial of memantine extended

release (ER) /donepezil HCl in patients with

moderate to severe Alzheimer's disease on a

stable dose of donepezil.

Donepezil/memantine 700217746 (Clinical Trials Insight)III

Recruiting double-blind 01 May 2008 (actual) 01 Oct 2008 (planned)

Planning 01 Mar 2008 (planned) Accera

52

A Pilot Study Comparing Inflammatory

Biomarkers in Blood and CSF in Patients With

Alzheimer's Disease and Age-Matched Controls



National Institutes of Health), R07-63

III

51

A phase III trial to investigate the efficacy and

safety of AC 1202 [Ketasyn] in patients with mild-

to-moderate Alzheimer's disease who are non-

carriers of the apolipoprotein E4 allele (APOE4).

AC-1202 700024265 (Clinical Trials Insight)III

01 Jul 2013 (planned) 01 Jun 2017 (planned) Lundbeck A/S, Otsuka Pharmaceutical

Development & Commercialization

50

A Phase 3, 12-week, Multicenter, Randomized,

Double-blind, Placebo Controlled Trial to Evaluate

the Efficacy, Safety, and Tolerability of 3 Fixed

Doses of Brexpiprazole (OPC 34712) in the

Treatment of Subjects With Agitation Associated

With Dementia of the Alzheimer's Type

Brexpiprazole 331-12-283 (Otsuka Pharmaceutical

Development and Commercialization,

Inc.), 700233327 (Clinical Trials




III Not yet recruiting

25 May 2011 (actual) 01 Dec 2016 (planned) AB Science

49

A multicenter, double-blind, placebo-controlled,

randomised, parallel-group phase 3 study to

evaluate the safety and efficacy of masitinib in

patients with mild to moderate Alzheimer's

disease [Estudio fase III, multicentrico, doble

ciego, randomizado, de grupos paralelos y

controlado con placebo para evaluar la eficacia y

seguridad de masitinib en pacientes con

enfermedad de Alzheimer de leve a [CONT.]


AB09004 (AB Science), EudraCT2010-





III Recruiting

Active, no longer recruiting 01 Jul 2009 (actual) 01 Sep 2013 (planned)

Recruiting 14 Feb 2012 (actual) 31 Mar 2015 (planned) Archer Pharmaceuticals

48

A Multi-Center Randomized Placebo-Controlled

Clinical Trial Study of Citalopram for the

Treatment of Agitation in Alzheimer's Disease.

Citalopram 700044474 (Clinical Trials Insight),



National Institutes of Health),

R01AG031348 (National Institute on

III

01 May 2010 (actual) 01 May 2012 (planned) SK Chemicals

47

A European multicenre double-blind placebo

controlled phase III trial of nilvadipine in mild to

moderate Alzheimer's disease.

Nilvadipine 12LO1903 (Multicentre Research Ethics

Committee (MREC)), 14485052

(ISRCTN: Current Controlled Trials),





Database), NILVAD2012 (St James's

III

46

A Confirmatory Trial of SK-PC-B70M in Mild to

Moderate Alzheimer's Disease.



National Institutes of Health), SMART-

AD-III2009

III Recruiting

III Recruiting 01 Sep 2011 (actual) 01 Nov 2012 (planned) Eisai Co Ltd, Eisai Inc

III Recruiting 30 Jun 2012 (actual) 01 Jul 2014 (planned) Novartis, Ono Pharmaceutical

45

A 24-weeks, Multi-center, Randomized, Double-

blind, Placebo Controlled Study to Evaluate the

Efficacy and Safety of Donepezil Hydrochloride in

Chinese Subjects With Severe Alzheimer's

Disease.


E2020C086-339 (Eisai Co),



III Recruiting 01 Jan 2010 (actual) 01 Jul 2014 (planned)

44

A 24-week, Multicenter, Parallel-group,

Randomized,Double-blind Study to Evaluate the

Tolerability, Safety and Efficacy of 2 Different

Titration Methods of Rivastigmine Patch

(ENA713D/ONO-2540) in Patients With Mild to

Moderate Alzheimer's Disease (MMSE 10-20)


CENA713D1303 (Novartis), MMSE10-

20, NCT01614886 (ClinicalTrials.gov:

US National Institutes of Health)

baseline comparison Drug utilisation 01 Mar 2012 (actual) 01 Oct 2014 (planned)

43

A 12-week, Multicenter, Randomized, Double-

blind, Placebo-controlled Trial of Bupropion for

the Treatment of Apathy in Alzheimer's

Dementia(Apa-AD).

Bupropion 155-09 (Ethik-Kommission der

Medizinischen Fakultat der Rheinischen

Friedrich-Wilhelms-Universitat Bonn),

4035568 (University Hospital Bonn),


apaalz01 (University Bonn),

DRKS00000103 (German Clinical Trials

Register), EudraCT2007-005352-17


NCT01047254 (ClinicalTrials. [CONT.]

30 Mar 2009 (actual) 30 Mar 2013 (planned)

42

Use of Alternative Medicine Among Patients With

Dementia and Mild Cognitive Dysfunction

Alternative-medicine 2011-1705REK (University Hospital of

North Norway), 700215118 (Clinical



IV Recruiting

41

The treatment of dementia with

acetylcholinesterase inhibitors: analysis of

plasma concentrations, drug interactions and

therapeutic effect as a function of genetic

polymorphisms [Die antidementive Therapie mit

Acetylcholinesteraseinhibitoren: Untersuchung

von Plasmakonzentrationen,

Arzneimittelinteraktionen und Therapieeffekt in

Abhangigkeit von genetischen Polymorphismen]


70639 (Medizinische Universitat

Innsbruck), EudraCT2008-005472-27

(European Clinical Trials Database)

IV Recruiting

multicentre drug dosage comparison

parallel placebo comparison

prospective

double-blind baseline comparison Cognitive function tests Magnetic-resonance-imaging-outcomes

multicentre placebo comparison Magnetic resonance imaging outcomes

parallel

randomised

double-blind baseline comparison Cognitive function tests Cognitive-function-tests

multicentre drug + nondrug vs nondrug comparison Cost:effectiveness ratio

parallel drug vs drug + nondrug comparison Magnetic resonance imaging outcomes

prospective drug vs nondrug comparison Patient compliance

randomised placebo comparison

multicentre baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


open patient comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryparallel Bodyweight

prospective Caregiver assessment


Frontal Assessment Battery




Resource use

Vital signs

open Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale

parallel Alzheimer's Disease Assessment Scale

prospective Instrumental Activities of Daily Living Scale


open baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale

parallel patient comparison Alzheimer's Disease Assessment Scale

Instrumental Activities of Daily Living Scale


multicentre Alzheimer's Disease Assessment Scale ECG-changes

open Alzheimer's Disease Cooperative Study Activities


Laboratory-parameters

prospective Amyloid levels Vital-signs



ECG changes

EuroQoL





Positron emission tomography imaging outcomes

Quality of life instrument

Resource use [CONT.]

64

Does premorbid IQ influence response to drug

treatment for dementia?


inhibitors

III Active, no longer recruiting Mini Mental State Examination 01 Jun 2006 (actual) 01 May 2007 (planned) 700014875 (Clinical Trials Insight),

N0120179697 (National Research

Register: National Health Service)double-blind Clinical Global Impressions scale Clinical-Global-Impressions-scale

parallel Positive and Negative Syndrome Scale Positive-and-Negative-Syndrome-Scale

randomised

double-blind baseline comparison Clinical improvement Cognitive-function-tests

randomised placebo comparison Cognitive function tests



subpart






parallel Amyloid levels

prospective Area under the drug concentration time curve

randomised Biomarker levels


EuroQoL





[CONT.]parallel drug dosage comparison Blood pressure Mini-Mental-State-Examination

prospective placebo comparison Haemodynamic parameters


single-blind

Colecalciferol double-blind baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

Memantine parallel drug combination comparison Alzheimer's Disease Assessment Scale cognitive

subpartprospective placebo comparison Calcium levels

randomised Cognitive function tests

Instrumental Activities of Daily Living Scale


Motor function

Parathyroid hormone levels

Patient compliance



Vitamin D levels

crossover baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

multicentre drug formulation comparison Geriatric Depression Scale

open Mini Mental State Examination

Patient Global Impressions scale

Physician Global Assessment

71Phase III trial of ELND 005 in patients with

Alzheimer's disease.

ELND-005 III Planning randomised Elan Corporation, Transition Therapeutics 700022361 (Clinical Trials Insight),

700058272 (Clinical Trials Insight)

72Phase III trial of EVP 6124 in patients with


EVP-6124 III Planning prospective EnVivo Pharmaceuticals 700220421 (Clinical Trials Insight)

multicentre

prospective

74

Pivotal phase III trial for TTP 488 in patients with

mild to moderate Alzheimer's disease

TTP-488 III Planning prospective TransTech Pharma 700234734 (Clinical Trials Insight)

Donepezil multicentre

LU-AE-58054 prospective

double-blind baseline comparison Alzheimer's Disease Cooperative Study Clinical

Global Impression of Change

Alzheimer's-Disease-Cooperative-Study-Clinical-Global-

Impression-of-Change

open placebo comparison Brief Psychiatric Rating Scale Neuropsychiatric-Inventory

Recruiting 01 Mar 2010 (actual) 01 Jul 2014 (planned)

76

Prazosin Treatment for Disruptive Agitation in


Prazosin 1RO1AG033133-01A1 (Seattle

Institute for Biomedical and Clinical

Research), 700056382 (Clinical Trials




III

Lundbeck A/SPlanning 01 Dec 2013 (planned)

Takeda Pharmaceuticals USA

75Pivotal phase III trial of LU AE58054, as an

adjunct to donepezil, for the treatment of


700226620 (Clinical Trials Insight)III

73Phase III trial of low dosage pioglitazone to delay

mild cognitive impairment caused by Alzheimer's

disease.

Pioglitazone 700234876 (Clinical Trials Insight)III Not yet recruiting

70

Evaluation of efficacy and safety of Memantine

ER versus Memantine IR in the treatment of

moderate to severe Alzheimer's disease: an open

label, switch-over, comparative, multi-centric

study.


CTRI2009-091-000977 (Clinical Trials

Registry - India), SUN-MEER0709 (Sun

Pharmaceutical Industries),

UTRN023537300-2311200914691909

(Clinical Trials Registry - India:

III

Recruiting 01 Sep 2011 (actual) 01 Feb 2013 (planned)

Not yet recruiting 30 Jan 2013 (planned)

69

Evaluation d'Une strategie therapeutique

d'Association medicamenteuse Pour la Prise en

Charge de la Maladie d'Alzheimer et Des Maladies

apparentees au Stade modere.



Clinical Trials Database),



III

68

Effect of plasmalogen -containing food on

cognitive function in patients with Alzheimer

disease - a single-blind trial

Plasmalogens 700228652 (Clinical Trials Insight),



III


BMHC3495 (Beersheva Mental Health

Center), NCT00190021


III Not yet recruiting placebo comparison

III Not yet recruiting 01 Aug 2013 (planned) 01 Dec 2016 (planned) Eli Lilly

Recruiting 04 Dec 2009 (actual) Sun Pharmaceutical Industries

III Recruiting 13 Jun 2006 (actual) 13 Dec 2008 (planned)

29 Nov 2010 (actual) 01 Jun 2016 (planned) Eli Lilly

Recruiting 01 Mar 2007 (actual) 01 Dec 2012 (planned) Eisai Korea

67

Effect of Passive Immunization on the

Progression of Mild Alzheimer's Disease:

Solanezumab (LY2062430) Versus Placebo

Solanezumab 15136 (Eli Lilly and Company),


H8A-MC-LZAX (Eli Lilly and Company),



66

EFFECT OF MEMANTINE TREATMENT ON BRAIN

FUNCTION AND MORPHOLOGICAL STRUCTURE

IN PATIENTS WITH MODERATE TO SEVERE

PATIENTS WITH ALZHEIMER S DISEASE A

STRUCTURAL MR AND FMRI STUDY




(Fondazione Santa Lucia)

65

Donepezil as Add-On Treatment of Psychotic

Symptoms in Patients With Dementia of the

Alzheimer's Type.

Donepezil

63

Continued Efficacy and Safety Monitoring of

Solanezumab, an Anti-Amyloid beta Antibody in

Patients With Alzheimer's Disease.

Solanezumab 11935 (Eli Lilly and Company),





Research Network), DeNDRoN032ext

(DeNDRoN Institute for Aging and

Health), EudraCT2010-021155-11


H8A-MC-LZAO (Eli Lilly Secondary

Identifier), NCT01127633

(ClinicalTrials. [CONT.]

III

62

Comparative Assessment of Clinical Efficacy of

Donepezil Between the Patients With Alzheimer's

Disease and Mixed Dementia.

Donepezil 2007-03-039 (Samsung Medical




III

Recruiting patient comparison 01 Feb 2008 (actual) 01 Dec 2012 (planned) Eisai Korea

Active, no longer recruiting 01 Jun 2011 (actual) 01 Dec 2012 (planned) Novartis

61

Comparative Assessment of Clinical Efficacy of

Donepezil Between the Naive Group and the

Switching Group.

Donepezil 2008-02-072 (Samsung Medical




III

Active, no longer recruiting baseline comparison

Active, no longer recruiting 01 May 2008 (actual) 01 Feb 2014 (planned)

60

Changes of cognitive function in patients with

mild to moderate Alzheimer's disease associated

with or without white matter lesions after

RivastigminE patch thERapy - A multi-center,

prospective, open-label clinical trial (CAREER

study)

Rivastigmine 11-48 (Dong-A University Medical

Center Institutional Review Board), 11-

48 (Novartis Korea), 700201501

(Clinical Trials Insight), A102065

(Ministry of Health and Welfare),

KCT0000551 (Clinical Research

Information Service (CriS) - Republic of

Korea), NCT01380288



III

Not yet recruiting Eisai Co Ltd

59

Assessment of the Efficacy of Omega-3 Fatty

Acids Supplementation, Multi-domain

Intervention or Their Combination on the Change

of Cognitive Functions in Frail Elderly Subjects

Docosahexaenoic-acid 07-116-03 (University Hospital,

Toulouse), 11-31-01 (University

Hospital, Toulouse), 700203970

(Clinical Trials Insight), NCT00672685


Institutes of Health), NCT01513252



III

01 May 2006 (actual) BELLUS Health

58

Assessment of the comparative effect of

donepezil 10mg/d and placebo on radiological

and biological markers in patients with amnestic

mild cognitive impairment

Donepezil 700038120 (Clinical Trials Insight)III

57

An Open-Label Extension of the Phase III Study

CL-758007 With Tramiprosate (3APS) in Patients

With Alzheimer's Disease

Tramiprosate 700006205 (Clinical Trials Insight),


CL758007 (BELLUS Health), CL758017

(BELLUS Health), NCT00314912



III Active, no longer recruiting Clinical response

parallel Duration of treatment


randomised

Cholinesterase-inhibitors open baseline comparison Mini-Mental-State-Examination

Memantine parallel drug combination comparison

prospective

randomised


subpart


multicentre drug dosage comparison Alzheimer's Disease Cooperative Study Activities




parallel placebo comparison Alzheimer's Disease Cooperative Study Clinical


Maximum-tolerated-dose

prospective Brain volume

randomised Computerised tomography imaging outcomes

ECG changes

Glucose uptake decline

Haemoglobin level



Maximum tolerated dose [CONT.]


subpart






parallel Alzheimer's Disease Cooperative Study Clinical


Glucose-uptake-decline

prospective Amyloid levels

randomised Apolipoprotein E level

Biomarker levels

Brain volume

Computerised tomography imaging outcomes

ECG changes

Gene expression

Glucose uptake decline

Laboratory parameters [CONT.]

double-blind baseline comparison Clinician's Interview Based Impression of Change

Plus


multicentre drug dosage comparison Severe Impairment Battery Severe-Impairment-Battery

parallel

prospective

randomised

double-blind baseline comparison Clinical response rate Hopkins-Verbal-Learning-Test

parallel placebo comparison Cognitive function

prospective Hopkins Verbal Learning Test

randomised Quality of life

parallel baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

prospective control group comparison Alzheimer's Disease Assessment Scale cognitive

subpart


randomised Barthel Index Mini-Mental-State-Examination

single-blind Cognitive function



prospective baseline comparison Biomarker levels Cognitive-function

randomised control group comparison Cognitive function

placebo comparison


subpart



of Daily Living Inventoryparallel Alzheimer's Disease Cooperative Study Clinical

Global Impression of Changeprospective Cognitive function tests

randomised Laboratory parameters


Pharmacokinetic parameters

Quality of Life in Alzheimers Disease Scale

Resource Utilisation in Dementia Questionnaire

double-blind baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale

multicentre drug formulation comparison Alzheimer's Disease Assessment Scale

parallel placebo comparison Clinician's Interview Based Impression of Change

Plusprospective Neuropsychiatric Inventory

randomised

Albumin-human multicentre baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


Immune-globulin parallel control group comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryprospective drug dosage comparison Alzheimer's Disease Cooperative Study Clinical

Global Impression of Changerandomised Amyloid levels

single-blind Cognitive function tests

Columbia Suicide Severity Rating Scale

Cornell Scale for Depression in Dementia



Gantenerumab double-blind baseline comparison Amyloid levels Amyloid-levels

Solanezumab multicentre drug comparison Assessment scale scores Biomarker-levels





Geriatric Depression Scale

Groton Maze Learning Task


Metabolic parameters




Tau levels

Wechsler Adult Intelligence Scale

Wechsler Memory Scale


subpart






parallel placebo comparison Amyloid levels

prospective Biomarker levels

randomised Brain volume


Clinical response rate





Tau levels

01 Nov 2012 (actual) 01 Apr 2017 (planned) Merck & Co, Merck Sharp & Dohme

88

A Randomized, Placebo Controlled, Parallel-

Group, Double Blind Efficacy and Safety Trial of

MK-8931 in Subjects With Mild to Moderate


MK-8931 12929 (United Kingdom Clinical

Research Network), 362812 (Australian

New Zealand Clinical Trials Registry

Request Number), 700222260 (Clinical

Trials Insight), 8931-017,

ACTRN12612000869875 (Australian

New Zealand Clinical Trials Registry),

DeNDRoN079MSD (Dementias and

Neurodegenerative Diseases Research

Network), EudraCT2011-003151-20


MK8931-017 (Merck and Co), MK8931-

017-02, MK8931-017-03 (Merck and

Co), NCT01739348 (ClinicalTrials

II/III Recruiting


DIAN-TU001 (Washington University

School of Medicine), DIAN-TUU12-

243040 (The Alzheimer's Association),



01 Dec 2012 (actual) 01 Dec 2016 (planned) Eli Lilly, Roche

87

A Phase II/III Randomized, Double-Blind,

Placebo-Controlled Multi-Center Study of 2

Potential Disease Modifying Therapies in

Individuals at Risk for and With Dominantly

Inherited Alzheimer's Disease

II/III Recruiting

01 Mar 2012 (actual) 01 Dec 2014 (planned) Grifols

86

A Multicenter, Randomized, Controlled Study To

Evaluate The Efficacy And Safety Of Short-Term

Plasma Exchange Followed By Long-Term

Plasmapheresis With Human Albumin Combined

With Intravenous Immunoglobulin In Patients

With Mild-Moderate AD


IG1002 (Grifols Biologicals (Instituto

Grifols SA)), NCT01561053



II/III Recruiting

Recruiting 01 May 2010 (actual) 01 Jun 2012 (planned) Shandong Luye Pharmaceutical

85

A Multi-Center, Randomized, Double-Blind,

Double-Dummy, Placebo- and Active-Controlled,

Study to Evaluate the Safety and Efficacy of

Huperzine A Sustained-Release Tablets in

Patients With Mild to Moderate Alzheimer's

Disease.

Huperzine-A 700193943 (Clinical Trials Insight),

LY200901-04 (Shandong Luye

Pharmaceutical Co.), NCT01282619



II/III

III Recruiting

84

A 26-Week, Double-blind, Randomized, Placebo-

controlled, Parallel-group Study to Investigate

the Effects of Daily Administration of AC-1204 in

Participants With Mild to Moderate Alzheimer's

Disease (AD) With an Optional 26-Week Open

Label Extension

AC-1204 700225727 (Clinical Trials Insight),

AC12-010 (Accera), NCT01741194



II/III

83

The A4 Trial: Anti-Amyloid Treatment of

Asymptomatic Alzheimer's Disease

Amyloid-beta-protein-

inhibitors

700221965 (Clinical Trials Insight)III

82

Study in the effect of Citrus Reticulata peels on

the cognitive function in the patients with

Alzheimer Disease.

Herbal-medicines 700194490 (Clinical Trials Insight),



III

Not yet recruiting 01 Sep 2012 (planned) 01 Aug 2017 (planned)

Active, no longer recruiting 01 Jun 2010 (actual)

81

Rivastigmine Patch in Veterans With Cognitive

Impairment Following TBI


CCTA0001, CLIN003-10S (Department

of Veterans Affairs), NCT01670526



III

Recruiting 01 Mar 2013 (actual) 01 Jan 2015 (planned) Accera

01 Mar 2012 (actual) 01 Nov 2014 (planned) Eisai Inc

Not yet recruiting

80

Randomized, Multicenter, Double-blind, Double-

dummy, Parallel-Group Study With an Open-label

Extension Phase to Compare the Efficacy and

Safety of Donepezil Hydrochloride 23 mg

Treatment With Continuation of Donepezil

Hydrochloride 10 mg Treatment in Japanese

Subjects With Severe Alzheimer's Disease


E2020J081-343 (Eisai Inc),



79

Randomized, Double-Blind, Placebo-Controlled,

Parallel-Group, 18-Month Safety and Efficacy

Study of TRx0237 in Subjects With Mild


TRx-0237 700223431 (Clinical Trials Insight),




National Institutes of Health), TRx237-

005 (TauRx Therapeutics)

III

Recruiting 30 Oct 2012 (actual) 01 Mar 2015 (planned) TauRx Therapeutics

78

Randomized, Double-Blind, Placebo-Controlled,

Parallel-Group, 12-Month Trial of Leuco-

methylthioninium bis(hydromethanesulfonate) in

Subjects with Mild to Moderate Alzheimer's

Disease [Ensayo aleatorizado, doble ciego, con

grupos paralelos, controlado con placebo de 12

meses de duracion de leuco metiltioninio bis

(hidrometanosulfonato) en pacientes con

enfermedad de Alzheimer de leve a [CONT.]

TRx-0237 14317 (United Kingdom Clinical




Diseases Research Network),





TauRx237-015, TRx237-015 (TauRx

Therapeutics)

III

Recruiting 30 Oct 2012 (actual) 01 Jul 2015 (planned) TauRx Therapeutics

Mini Mental State Examination 01 May 2013 (actual)

77

Randomized, an open controlled trial of

memantine in moderate Alzheimer's disease

already receiving cholinesterase inhibitors.




III Recruiting

Recruiting 01 Mar 2010 (actual) 01 Jul 2014 (planned)

76

Prazosin Treatment for Disruptive Agitation in


Prazosin 1RO1AG033133-01A1 (Seattle

Institute for Biomedical and Clinical

Research), 700056382 (Clinical Trials




III

double-blind baseline comparison Calcium levels Trail-Making-Test-Part-B

parallel placebo comparison Five Times Sit to Stand Test

prospective Patient compliance

randomised Processing Speed Index

Stroop Test

Timed Get Up And Go Test



Vitamin D levels

Walking test

Crocus double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


Memantine parallel drug comparison Clinical Dementia Rating

prospective

randomised

double-blind baseline comparison Alzheimer's Disease Assessment Scale Amyloid-levels

multicentre drug dosage comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Clinical-Dementia-Rating

parallel placebo comparison Amyloid levels

prospective Antibody levels

randomised Assessment scale scores

Biomarker levels

Brain volume

Cambridge Neuropsychological Test Automated

BatteryClinical Dementia Rating

Clinical response

Cognitive function

Drug concentration

ECG changes

Gene expression

Haematological response

Magnetic resonance imaging outcomes [CONT.]

double-blind Alzheimer's Disease Assessment Scale cognitive

subpart


multicentre Apolipoprotein E level Clinical-response

parallel California Verbal Learning Test Clinician's-Interview-Based-Impression-of-Change-Plus

prospective Clinical response

randomised Clinician's Interview Based Impression of Change

PlusLetter and Category Fluency





WHO Quality of Life BREF


subpart


multicentre patient comparison Alzheimer's Disease Cooperative Study Activities




parallel placebo comparison Amyloid levels Amyloid-levels

prospective Biomarker levels Biomarker-levels

randomised Buschke Selective Reminding Test Buschke-Selective-Reminding-Test

Clinical improvement rate Cognitive-function-tests

Cognitive function tests Gene-expression

Gene expression Magnetic-resonance-imaging-outcomes

Magnetic resonance imaging outcomes Working-memory

Working memory

double-blind baseline comparison Biomarker levels Cognitive-function-tests


prospective

randomised

double-blind baseline comparison Amyloid levels

multicentre placebo comparison Global Assessment of Functioning

parallel

prospective

randomised

multicentre Alzheimer's Disease Cooperative Study Clinical


Caregiver-assessment

open Caregiver assessment Cognitive-function

parallel Cognitive function




subpart

Computerised-tomography-changes


prospective Computerised tomography changes

randomised Inflammatory markers

double-blind baseline comparison Assessment scale scores Clinical-Dementia-Rating

multicentre placebo comparison Brain volume

parallel Clinical Dementia Rating

prospective Cognitive function

randomised Geriatric Depression Scale

Immunological response

Kaplan meier survival rate



Time to disease progression


subpart


parallel placebo comparison Biomarker levels Clinical-Dementia-Rating

prospective Clinical Dementia Rating

randomised Cognitive function

Hormone levels



Performance status


subpart

Amyloid-levels

parallel placebo comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryprospective Amyloid levels

randomised Apolipoprotein E level

Biomarker levels





double-blind Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

multicentre Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryparallel Mini Mental State Examination


control group comparison 01 Sep 2009 (actual) 01 Dec 2014 (planned) Ceregene

101

A Double-Blind, Placebo-Controlled (Sham

Surgery), Randomized, Multicenter Study

Evaluating CERE-110 Gene Delivery in Subjects

With Mild to Moderate Alzheimer's Disease.

CERE-110 700038940 (Clinical Trials Insight),

CERE110-03 (Ceregene),



II Active, no longer recruiting

Recruiting 01 Feb 2013 (actual) 01 Mar 2014 (planned) ReXceptor

100

A Double Blind Placebo Controlled Randomized

Study to Evaluate the Efficacy and Safety of

Bexarotene in Patients With Mild to Moderate

Alzheimer's Disease

Bexarotene 700229000 (Clinical Trials Insight),

CCF-IRB12-783 (The Cleveland Clinic),



II

ELND-005 700225794 (Clinical Trials Insight),


ELND005AG251 (Elan

Pharmaceuticals), EudraCT2012-





II

01 Nov 2010 (actual) 01 Dec 2015 (planned)

14 Dec 2011 (actual) 01 Sep 2016 (planned) Avraham Pharmaceuticals

99

A Clinical Trial of Exendin-4 for the Treatment of

Alzheimer's Disease

Exenatide 10AG-N423, 700192169 (Clinical Trials

Insight), 999910423 (National

Institutes of Health Clinical Center

(CC)), NCT01255163



II Recruiting

94

Twenty-Four-Week, Randomized, Double-Blind,

Placebo-Controlled, Parallel Group Study of the

Effect of Fixed Dose Regimens of Thalidomide

and Placebo on CSF and Plasma Biomarkers in

Patients With Mild to Moderate Alzheimer's

Disease.

Thalidomide 700055017 (Clinical Trials Insight),



II/III

01 Jul 2011 (actual) 01 May 2013 (planned) Metabolic Solutions Development Company

98

A 36-month, Multi-centre, Randomized, Double

Blind, Placebo-controlled Study to Evaluate the

Safety and Efficacy of Low Dose Ladostigil in

Patients With Mild Cognitive Impairment (MCI).

Ladostigil 700206145 (Clinical Trials Insight),

CO17730 (Avraham Pharmaceuticals),






97

A 3-month Randomized, Double-Blind, Placebo-

Controlled, Feasibility Study to Evaluate the

Effects of MSDC-0160 on Brain Glucose

Utilization, Cognition, Safety and Tolerability in

Older Persons With Mild Alzheimer's Disease.

MSDC-0160 700200842 (Clinical Trials Insight),

MSDC0160C006 (Metabolic Solutions

Development Company), NCT01374438




Recruiting baseline comparison 01 Jan 2013 (actual) 01 Mar 2014 (planned) Elan Pharma International, Elan Pharmaceuticals

96

A 12-Week Safety Extension Study of Oral

ELND005 for Treatment of Agitation and

Aggression in Patients With Moderate to Severe

Alzheimer's Disease [Estudio de extension de 12

semanas para evaluar la seguridad de ELND005

oral para el tratamiento de la agitacion y la

agresividad en pacientes con enfermedad de

Alzheimer moderada o grave] [EXTENSION OF

700225794]

93

Therapeutic Effects of Intranasally-Administered

Insulin in Adults With Amnestic Mild Cognitive

Impairment (aMCI) or Mild Alzheimer's Disease

(AD)

Insulin 700228299 (Clinical Trials Insight),

ADC046INI (Alzheimer's Disease

Cooperative Study), NCT01767909



II/III Not yet recruiting

Recruiting baseline comparison 07 May 2009 (actual)

II Recruiting 01 Aug 2012 (actual) 01 Feb 2014 (planned) Rock Creek Pharmaceuticals

Recruiting 01 Mar 2010 (actual) 01 Jan 2013 (planned)

95

3-Month, Single Site or Multi-Site, Double Blind,

Randomized, Placebo-Controlled, Parallel-Group

Trial to Evaluate the Safety Tolerability and

Potential Effects of the Dietary Supplement

Anatabloc(R) in Subjects With Alzheimer's

Disease

Anatabine 700222198 (Clinical Trials Insight),


National Institutes of Health), RCP009

(Rock Creek Pharmaceuticals)

01 Sep 2013 (planned) 01 Oct 2014 (planned)

92

Sunphenon EGCg (Epigallocatechin-Gallat) in the

early stage of Alzheimer's Disease

Epigallocatechin-gallate 700216289 (Clinical Trials Insight),


Clinical Trials Database)

II/III

II/III Recruiting 01 Nov 2010 (actual) 01 Sep 2016 (planned) Roche

03 Apr 2012 (actual) 05 May 2013 (planned)

91

Multicenter, Randomized, Double-Blind, Placebo-

Controlled, Parallel-Group Two Year Study to

Evaluate the Effect of Subcutaneous RO4909832

on Cognition and Function in Prodromal

Alzheimer's Disease with Option for an Additional

Two Years of Treatment

Gantenerumab 11916 (United Kingdom Clinical


(Clinical Trials Insight), 8686 (United


DeNDRoN055 (Dementias and


Network), DeNDRoN084 (Dementias

and Neurodegenerative Diseases

Research Network), EudraCT2010-


Database), IRB00008026 (Oregon

Health and Science University

Institutional Review Board),

NCT01224106 (ClinicalTrials [CONT.]

Recruiting 01 Nov 2012 (actual) 01 Nov 2014 (planned) Nutrisante Laboratories

90

Effect of Saffron Versus Memantine in patients

with severe Alzheimer's disease: randomized

double-blind placebo-controlled study.


IRCT201203051556N39 (Iranian

Registry of Clinical Trials)

II/III Active, no longer recruiting

89

DIetary Supplements, Executive funcTions and

Vitamin D (DIET-D): a Double-blind Randomized

Controlled Trial

Multimineral/multivitamin/

nutritional-trace-element

2012A00453-40 (University Hospital,

Angers), 700224582 (Clinical Trials




II/III

randomised Neuropsychological Test Battery

crossover drug dosage comparison Area under the drug concentration time curve Cognitive-function-tests

double-blind placebo comparison Cognitive function tests Symptoms

randomised Drug concentration

Peak drug concentration

Symptoms

Time to peak drug concentration


subpart


parallel drug dosage comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryprospective placebo comparison Clinical Dementia Rating



crossover Assessment scale scores Cognitive-function-tests

double-blind Cognitive function tests Repeatable-Battery-for-Assessment-of-

Neuropsychological-Status

prospective Repeatable Battery for Assessment of

Neuropsychological Status

Trail-Making-Test-Part-A

randomised Trail Making Test Part A Trail-Making-Test-Part-B



subpart


Ispronicline multicentre drug comparison Alzheimer's Disease Cooperative Study Activities




parallel placebo comparison Apolipoprotein E level Clinician's-Interview-Based-Impression-of-Change-Plus

prospective Clinician's Interview Based Impression of Change

Plusrandomised Gene expression




Quality of life

Resource Utilisation in Dementia Questionnaire

Response rate


subpart


parallel placebo comparison Behavioural Pathology in Alzheimer's Disease

Rating Scalerandomised Clinical Dementia Rating


PlusInstrumental Activities of Daily Living Scale


Donepezil double-blind baseline comparison

Tesofensine multicentre drug combination comparison


prospective

randomised

multicentre baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Antibody-levels

open route of administration comparison Alzheimer's Disease Cooperative Study Activities


Magnetic-resonance-imaging-outcomes

prospective Antibody levels

Biomarker levels

Brain volume


Dependence Scale

Digit Symbol Substitution Test

Disease progression

Drug concentration

Letter and Category Fluency



Pharmacokinetic parameters [CONT.]

double-blind drug dosage comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart


subpartparallel Clinical Dementia Rating

prospective Mini Mental State Examination



QS-21 double-blind baseline comparison Amyloid levels Amyloid-levels

Vanutide-cridificar multicentre drug dosage comparison Biomarker levels


prospective Immunological response

randomised

double-blind baseline comparison Alzheimer's Disease Assessment Scale

prospective placebo comparison Assessment scale scores

randomised Clinical Global Impressions scale

Cytokine levels

Improvement in symptoms




QS-21 double-blind baseline comparison Amyloid levels Amyloid-levels

Vanutide-cridificar multicentre drug dosage comparison Biomarker levels Dose-parameters



randomised Dose parameters



double-blind baseline comparison Alzheimer's Disease Cooperative Study Activities



multicentre placebo comparison Alzheimer's Disease Cooperative Study Clinical

Global Impression of Changeparallel Caregiver Strain Index


randomised Quality of Life in Alzheimers Disease Scale

Donepezil double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

STA-1 parallel drug combination comparison Mini Mental State Examination

prospective

randomised

double-blind baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

multicentre drug dosage comparison Alzheimer's Disease Assessment Scale cognitive

subpartparallel placebo comparison Clinician's Interview Based Impression of Change

Plusprospective Neuropsychiatric Inventory

randomised


subpart

Alzheimer's-Disease-Assessment-Scale-cognitive-subpart 19 Nov 2012 (actual) 01 Feb 2015 (planned) Roche

116

A phase II, multicenter, randomized, double-

blind, parallel-group, placebo-controlled study to

investigate the efficacy and safety of RO4602522

added to the background therapy of the

acetylcholinesterase inhibitors donepezil or

rivastigmine in patients with moderate severity




(Clinical Trials Insight), BP28248

(Hoffmann-La Roche), DeNDRON088







II Recruiting

Recruiting 01 Jun 2011 (actual) 01 Oct 2012 (planned)

01 Dec 2016 (planned) Sinphar Pharmaceutical Co Ltd

115

A Phase II, Double Blind, Placebo-controlled,

Randomized, Multi-Center, Parallel Group Dose

Exploring Study to Evaluate the Efficacy and

Safety of Octohydroaminoacridine Succinate

Tablets in Patient With Mild to Moderate

Alzheimer's Disease

Octohydroaminoacridine-

succinate


CCHY2010L00161HPAD2 (Changchun

Huayang High-Tech Company),



II

01 Jun 2012 (actual) 01 Mar 2014 (planned) Avanir Pharmaceuticals

114

A Phase II Double-blind, Randomized, Placebo-

controlled, Parallel-group Study to Evaluate the

Efficacy and Safety of STA-1 as an Add-on

Treatment to Donepezil in Patients With Mild to



MCCD09009A, NCT01255046



II Not yet recruiting 01 Jul 2014 (planned)

113

A Phase 2, Randomized, Double-dummy, Double-

blind, Placebo-controlled Study to Assess the

Efficacy, Safety and Tolerability of AVP-923

(Dextromethorphan/Quinidine) for the Treatment

of Symptoms of Agitation in Patients With


Dextromethorphan/quinidi

ne

12AVR131 (Avanir Pharmaceuticals),




II Recruiting

Active, no longer recruiting 01 Jan 2011 (actual) 01 Feb 2014 (planned) JANSSEN Alzheimer Immunotherapy, Pfizer

Active, no longer recruiting 01 Jan 2011 (actual) 01 Mar 2013 (planned) Pfizer

112

A Phase 2, Multicenter, 24-Month, Randomized,

Third-Party Unblinded, Placebo-Controlled,

Parallel-Group Amyloid Imaging Positron

Emission Tomography (Pet) And Safety Trial Of

Acc-001 And Qs-21 Adjuvant In Subjects With

Early Alzheimer's Disease.


B2571010 (Pfizer), NCT01227564



II

111

A Phase 2, Double-blind, Placebo-controlled

Study of the Safety and Tolerability of Etanercept

in Patients With Alzheimer's Disease.

Etanercept 10H0502-8 (Multicentre Research


(Clinical Trials Insight), 8471 (United






II

01 Jan 2011 (actual) 01 Feb 2014 (planned) Agenus, JANSSEN Alzheimer Immunotherapy,

Pfizer

110

A Phase 2, 24-Month, Multi-Center, Randomized,

Double-Blind, Placebo-Controlled, Parallel-Group,

Amyloid-Imaging Positron Emission Tomography

(PET) and Safety Study of ACC-001 and QS-21

Adjuvant in Subjects With Mild to Moderate



ACC001ALZ2001 (Janssen Alzheimer

Immunotherapy Research and

Development), NCT01284387




Recruiting 01 May 2012 (actual) 01 May 2013 (planned) PuriMED

109

A Phase 2 Clinical Study to Explore the Optimal

Dosage/Administration of PM012 Tablet in

Alzheimer's Disease: Double-Blind, Randomized

Between Placebo Control Group and Dose

Groups, Parallel-Design, Multicenter Study

PM-012 700224953 (Clinical Trials Insight),


National Institutes of Health), PM012P2

(Purimed Co., Ltd.)

II

1198-022 (Boehringer Ingelheim

Pharma GmbH), 700199699 (Clinical


12 (European Clinical Trials Database)

II Recruiting

106

A Double-Blind, Randomized, Placebo Controlled

Study to Evaluate the Efficacy and Safety of DCB-

AD1 in Patients With Mild to Moderate


DCB-AD1 700206166 (Clinical Trials Insight),

931006, DCB-AD1-01-01,


National Institutes of Health), NTUH-

IRB931006 (National Taiwan University

Hospital, Institutional Review Board),

VGH-IRB93-11-06 (Taipei Veterans

General Hospital, Institutional Review

Board)

II






National Institutes of Health), TC1734-

226CRD006 (Targacept)

Genentech, Roche

108

A Multicenter, Open-Label, Long-Term Safety

Extension Of Phase II Studies ABE4869g And

ABE4955g In Patients With Mild To Moderate

Alzheimer's Disease

Crenezumab 13360 (UK Clinical Research Network),




DeNDRoN066ext (Dementias and




GN28525 (Genentech), NCT01723826



II Recruiting 30 Nov 2012 (actual) 01 Jul 2016 (planned)

19 Sep 2011 (actual) 01 Jul 2014 (planned) AstraZeneca, Targacept

105

A Double-Blind, Positive Comparator,

Randomized, Multicenter, Parallel Group Study to

Assess the Efficacy, Safety, and Tolerability of

AZD3480 (TC-1734-226) as Monotherapy in

Patients with Mild to Moderate Dementia of the

Alzheimer's Type (AD).


Pharmacokinetic parameters 05 Oct 2004 (actual) 05 Jul 2005 (planned)

Not yet recruiting 01 Sep 2005 (planned)

107

A multi-centre, double-blind, parallel-group,

randomised, placebo-controlled study to

investigate the safety and tolerability of 0.25, 0.5

and 1.0 mg NS 2330 orally and once daily during

a 14-week treatment period as add-on to 10 mg

donepezil once daily in patients with mild to

moderate dementia of the Alzheimer's type.

Active, no longer recruiting placebo comparison 01 Sep 2011 (actual) 01 Mar 2013 (planned)

Recruiting 01 Nov 2012 (actual) 01 May 2015 (planned) Mitsubishi Tanabe Pharma Corporation

104

A Double-Blind, Placebo-Controlled Single Dose

Study of the Safety and Efficacy of Glulisine on

Cognitive Function and Memory in Individuals

Diagnosed With Probable Mild to Moderate

Alzheimer's Disease/Intranasal Insulin Study.

Insulin-glulisine 11-111 (HealthPartners Research

Foundation), 700206691 (Clinical Trials




II

103

A Double-Blind, Placebo-Controlled Phase2 Study

of MT-4666 in Patients With Mild to Moderate

Probable Alzheimer's Disease.

EVP-6124 P211-03 (Mitsubishi Tanabe Pharma

Corporation), 700227925 (Clinical




II

Not yet recruiting 01 Apr 2008 (planned) 01 Sep 2008 (planned)

control group comparison 01 Sep 2009 (actual) 01 Dec 2014 (planned) Ceregene

102

A double-blind, placebo-controlled crossover

study to assess the pharmacokinetic profile and

the physiological and behavioral effects of repeat

rivastigmine (Exelon) administration in young

healthy male volunteers




TASMC07JA234CTIL (Tel-Aviv Sourasky

Medical Center), TRC032-10058

II

101

A Double-Blind, Placebo-Controlled (Sham

Surgery), Randomized, Multicenter Study

Evaluating CERE-110 Gene Delivery in Subjects


CERE-110 700038940 (Clinical Trials Insight),

CERE110-03 (Ceregene),




RG-1577 multicentre drug combination comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living InventoryRivastigmine parallel drug dosage comparison Alzheimer's Disease Cooperative Study Clinical

Global Impression of Changeprospective placebo comparison Apathy Evaluation Scale

randomised Behavioural Pathology in Alzheimer's Disease

Rating ScaleClinical Global Impressions scale

Global Deterioration Scale

Mini Mental State Examination [CONT.]

QS-21 double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpartVanutide-cridificar multicentre drug dosage comparison Amyloid levels

parallel Antibody levels



Dependence Scale

Immunoglobulin G levels

Immunoglobulin M levels





Protein levels

Quality of life

Resource use

QS-21 multicentre baseline comparison Alzheimer's Disease Assessment Scale Bodyweight

Vanutide-cridificar open drug dosage comparison Assessment scale scores ECG-changes

parallel Bodyweight Laboratory-parameters

prospective Cognitive function tests Magnetic-resonance-imaging-outcomes

ECG changes


Immunoglobulin M levels






subpart


MK-7622 multicentre drug combination comparison Assessment scale scores Treatment-discontinuation

parallel drug dosage comparison Treatment discontinuation

prospective placebo comparison

randomised

double-blind baseline comparison Amyloid levels Amyloid-levels

multicentre placebo comparison HDL cholesterol level HDL-cholesterol-level

parallel LDL cholesterol level

prospective Triglyceride levels

randomised

double-blind baseline comparison Amyloid levels Symptom-score

multicentre drug dosage comparison Brain volume

parallel drug regimen comparison Symptom score

prospective

randomised

double-blind baseline comparison Alzheimer's Disease Cooperative Study Activities



multicentre placebo comparison Alzheimer's Disease Cooperative Study Clinical


Symptom-severity

parallel Mini Mental State Examination


randomised Pharmacokinetic parameters

Symptom severity


multicentre placebo comparison Biomarker levels Biomarker-levels

parallel Brain volume Computerised-tomography-changes


randomised Neuropsychological Test Battery


subpartparallel drug dosage comparison Assessment scale scores

prospective placebo comparison Biomarker levels







subpart


multicentre placebo comparison Neuropsychiatric Inventory

parallel

prospective

randomised

double-blind drug dosage comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale


parallel Clinical response


randomised Gene expression


Quality of life


subpart






parallel Antibody levels Magnetic-resonance-imaging-outcomes

prospective Buschke Selective Reminding Test



Investigator's Global Assessment




Neuropsychological Test Battery [CONT.]

double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale-cognitive-subpart


subpart


parallel route of administration comparison Alzheimer's Disease Cooperative Study Activities


Clinical-Dementia-Rating

prospective Clinical Dementia Rating Mini-Mental-State-Examination



subpart

Amyloid-levels

multicentre placebo comparison Amyloid levels

Active, no longer recruiting 01 Jul 2011 (actual) 01 Jan 2014 (planned) Genentech, Roche

129

A Randomized, Double-Blind, Placebo Controlled,

Parallel-Group, Multicenter, Phase II Study to

Evaluate the Impact of MABT5102A on Brain

Amyloid Load and Related Biomarkers in Patients

With Mild to Moderate Alzheimer's Disease

Crenezumab 700202954 (Clinical Trials Insight),


ABE4955g (Genentech), EudraCT2010-


Database), GN00762 (Genentech),



II

Active, no longer recruiting 01 Apr 2011 (actual) 01 Mar 2014 (planned) Genentech

128



Evaluate the Efficacy and Safety of MABT5102A

in Patients With Mild to Moderate Alzheimer's

Disease (ABBY).

Crenezumab 10117 (United Kingdom Clinical


(Clinical Trials Insight), 700225862

(Clinical Trials Insight), ABE4869g

(Genentech), DeNDRoN066 (Dementias

and Neurodegenerative Diseases

Research Network), EudraCT2010-


Database), GN00761, NCT01343966


II

24 Jul 2015 (planned) AFFiRiS

01 Mar 2014 (planned) AFFiRiS

127

A randomized, controlled, parallel group, double-

blind, multi-centre, phase IIb study to assess

safety and clinical activity of continued AFFITOPE

AD02 vaccinations of patients who participated in

the AFFITOPE AD02 phase II study AFF006.

[CONT.]

Affitope-AD02 700051425 (Clinical Trials Insight),


AFF006A (AFFiRiS), EudraCT2012-


Database)

II Recruiting 24 Jan 2013 (actual)

126

A Randomized, Controlled, Parallel Group, Double-

blind, Multi-center, Phase II Study to Assess the

Clinical- and Immunological Activity,as Well as

the Safety and Tolerability of Different

Doses/Formulations of AFFITOPE AD02

Administered Repeatedly to Patients With Early


Affitope-AD02 AFFiRiS006 (AFFiRiS), EudraCT2009-




Institutes of Health), 700051425


(Clinical Trials Insight), AFF006

II Active, no longer recruiting 10 Mar 2010 (actual)

01 Nov 2012 (actual) 01 Apr 2014 (planned) Pfizer

125

A Randomized, 18-Week, Placebo-Controlled,

Double-Blind, Parallel Group Study Of The Safety

And Efficacy Of PF-05212377 (SAM-760) In

Subjects With Mild-To-Moderate Alzheimer's

Disease With Existing Neuropsychiatric

Symptoms On A Stable Daily Dose Of Donepezil

PF-5212377 700224787 (Clinical Trials Insight),

B2081011 (Pfizer), NCT01712074



II Recruiting

Recruiting 16 Nov 2011 (actual) Velacor Therapeutics

124

A Randomised, Double-Blind, Placebo-Controlled

Trial to Evaluate the Safety, Tolerability and the

Biological and Cognitive Effects of VEL015

(Sodium Selenate) in Patients with Mild to

Moderate Alzheimer's Disease - a Pilot Study

Sodium-selenate 083952 (Australian New Zealand





Registry), HREC10MH5 (Human

Research Ethics Committee (HREC).),

Velacor002 (Velacor Therapeutics)

II

Active, no longer recruiting 15 Dec 2011 (actual) 01 Dec 2013 (planned) Prana Biotechnology

123

A Randomised, Double-Blind, Placebo Controlled

Study to Assess the Safety and Tolerability of

PBT2, and its Effect on Amyloid Deposition in the

Brains of Patients with Prodromal or Mild


PBT-2 343427 (Australian New Zealand



Insight), 700234553 (Clinical Trials



Registry), PBT2-204 (Prana

Biotechnology), U1111-1124-2486

II

Recruiting 01 Nov 2012 (actual) 01 Dec 2013 (planned) Elan Pharmaceuticals

Recruiting 01 Dec 2012 (actual) 01 Dec 2016 (planned) Eisai Inc

122

A Prospective, Randomized, Double-Blind,

Placebo-Controlled, Phase 2 Efficacy and Safety

Study of Oral ELND005 for Treatment of

Agitation and Aggression in Patients With

Moderate to Severe Alzheimer's Disease [Estudio

fase 2 prospectivo, aleatorizado, doble ciego,

controlado con placebo, de eficacia y seguridad

de ELND005 oral para el tratamiento de la

agitacion y la agresividad en pacientes [CONT.]

ELND-005 13705 (United Kingdom Clinical



(Clinical Trials Insight), AG201 (Elan

Pharmaceuticals), DeNDRoN093


Diseases Research Network), ELND005-

AG201 (Elan Pharmaceuticals),



II

121

A Placebo-controlled, Double-blind, Parallel-

group, Bayesian Adaptive Randomization Design

and Dose Regimen-finding Study to Evaluate

Safety, Tolerability and Efficacy of BAN2401 in

Subjects With Early Alzheimer's Disease

BAN-2401 700228100 (Clinical Trials Insight),

BAN2401G000-201 (Eisai Inc.),



II

Not yet recruiting 01 May 2011 (planned) Arjuna Natural Extracts

120

A Pilot Clinical Study to Evaluate the Potential of

AMLAMAX (trademark (TM)) (Emblica Officinalis)

Extract on Raising HDL-Cholesterol levels and

Decreasing Plasma Amyloid beta Levels in

subjective memory complainers with low HDL-C.

Phyllanthus-emblica 336842 (Australian New Zealand





Registry), HPH300 (Hollywood Private

Hospital Human Research Ethics

Committee (HREC)), U1111-1120-

II

01 Oct 2013 (planned) 01 Nov 2015 (planned) Merck

119

A Phase IIb, Multicenter, Randomized, Double-

Blind, Placebo-Controlled, Parallel Group Study to

Evaluate the Efficacy and Safety of MK-7622 as

an Adjunctive Therapy to Donepezil for

Symptomatic Treatment in Subjects With

Alzheimer's Disease


7622-012 (Merck), EudraCT2013-


Database), MK7622-012AM1 (Merck),



II Not yet recruiting

Recruiting 01 Dec 2010 (actual) 01 Sep 2014 (planned) JANSSEN Alzheimer Immunotherapy, Pfizer,

Wyeth

118

A Phase Iia, Multicenter, Treatment Assigned,

Open-Label, Long-Term Extension Study To

Determine Safety, Tolerability, And

Immunogenicity Of ACC-001 With QS-21

Adjuvant In Japanese Subjects With Mild To

Moderate Alzheimer's Disease.

3134K1-2207 (Wyeth), 700037628



(Clinical Trials Insight), B2571001

(Pfizer), NCT01238991



II

18 Sep 2009 (actual) 01 Nov 2014 (planned) JANSSEN Alzheimer Immunotherapy, Pfizer,

Wyeth Pharmaceuticals

117

A Phase IIa, Multicenter, Randomized, Third-

Party Unblinded, Long-Term Extension Study To

Determine Safety, Tolerability, And

Immunogenicity Of ACC-001 With QS-21

Adjuvant In Subjects With Mild To Moderate

Alzheimer's Disease [EXTENSION OF

700025404]

3134K1-2203EU (Wyeth), 700025404


(Clinical Trials Insight), B2571007

(Pfizer), EudraCT2009-010922-21



National Institutes of Health), 3134K1-

2203 (Wyeth)


19 Nov 2012 (actual) 01 Feb 2015 (planned) Roche

116

A phase II, multicenter, randomized, double-

blind, parallel-group, placebo-controlled study to

investigate the efficacy and safety of RO4602522

added to the background therapy of the

acetylcholinesterase inhibitors donepezil or

rivastigmine in patients with moderate severity




(Clinical Trials Insight), BP28248

(Hoffmann-La Roche), DeNDRON088







II Recruiting

parallel route of administration comparison Biomarker levels

prospective Positron emission tomography imaging outcomes

randomised

ABT-126 double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


Donepezil multicentre drug comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryparallel drug dosage comparison Clinician's Interview Based Impression of Change

Plusprospective placebo comparison Columbia Suicide Severity Rating Scale

randomised Dementia Quality of Life

ECG changes

EuroQoL




Partner Patient Questionnaire for Shared

Activities [CONT.]ABT-126 double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


Donepezil multicentre drug combination comparison Alzheimer's Disease Cooperative Study Activities


Brief-Psychiatric-Rating-Scale

Rivastigmine parallel drug dosage comparison Brief Psychiatric Rating Scale Columbia-Suicide-Severity-Rating-Scale

prospective placebo comparison Clinician's Interview Based Impression of Change

Plus

Cornell-Scale-for-Depression-in-Dementia

randomised Cognitive function ECG-changes

Columbia Suicide Severity Rating Scale Laboratory-parameters

Cornell Scale for Depression in Dementia Neuropsychiatric-Inventory

Dementia Quality of Life Vital-signs

ECG changes

EuroQoL


Mini Mental State Examination [CONT.]

double-blind Columbia Suicide Severity Rating Scale Columbia-Suicide-Severity-Rating-Scale

multicentre Cornell Scale for Depression in Dementia Cornell-Scale-for-Depression-in-Dementia

open ECG changes ECG-changes

prospective

randomised

double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

parallel drug dosage comparison Alzheimer's Disease Cooperative Study Activities



randomised placebo comparison Blood pressure



PlusCognitive function tests

ECG changes

Heart rate


Protein C levels


crossover baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


double-blind placebo comparison Mini Mental State Examination

multicentre

prospective

randomised

double-blind Activities of Daily Living Scale Biomarker-levels

parallel Biomarker levels Molecular-response

prospective Cognitive function tests Response

randomised Molecular response


Response

Unified Huntington's Disease Rating Scale

open Alzheimer's Disease Cooperative Study Activities


Amyloid-levels

prospective Amyloid levels

Biomarker levels

Brain volume

Cognitive function



Neuropsychological Test Battery

crossover baseline comparison Area under the drug concentration time curve Area-under-the-drug-concentration-time-curve

open drug formulation comparison Drug half life Drug-half-life

randomised Peak drug concentration Peak-drug-concentration

Time to peak drug concentration Time-to-peak-drug-concentration


inhibitors

double-blind baseline comparison Caregiver time Mini-Mental-State-Examination

Choline-alfoscerate parallel placebo comparison Mini Mental State Examination Neuropsychiatric-Inventory


randomised


parallel placebo comparison Amyloid levels Cognitive-function-tests

randomised Assessment scale scores




Cornell Scale for Depression in Dementia



Symptoms

double-blind drug dosage comparison


subject comparison

141 Clinical Trials Insight: 700028325 CX-701 II Planning Cortex Pharmaceuticals 700028325 (Clinical Trials Insight)

142 Clinical Trials Insight: 700029331 SB-742457 II Planning GlaxoSmithKline 700029331 (Clinical Trials Insight)

143 Clinical Trials Insight: 700030491 Davunetide II Planning Allon Therapeutics 700030491 (Clinical Trials Insight)

double-blind Alzheimer's Disease Assessment Scale

multicentre Magnetic resonance imaging outcomes

parallel

randomised

145 Clinical Trials Insight: 700041101 Davunetide II Planning Allon Therapeutics 700041101 (Clinical Trials Insight)

146 Clinical Trials Insight: 700041103 Davunetide II Planning Computerised tomography changes Computerised-tomography-changes Allon Therapeutics 700041103 (Clinical Trials Insight)

147 Clinical Trials Insight: 700048839 Etazolate II Planning prospective ExonHit Therapeutics 700048839 (Clinical Trials Insight)

double-blind

prospective

149 Clinical Trials Insight: 700054973 NP-61 II Planning prospective 01 Jan 2009 (planned) Noscira 700054973 (Clinical Trials Insight)

150 Clinical Trials Insight: 700058583 Leuprorelin II Planning Curaxis Pharmaceutical Corp. 700058583 (Clinical Trials Insight)

double-blind baseline comparison Cambridge Neuropsychological Test Automated

Battery

Cognitive-function-tests

multicentre patient comparison Cognitive function tests

parallel placebo comparison Laboratory parameters

26 May 2011 (actual)

151

Comparative study on the effect of intranasal

insulin on cognitive function in patients with type

2 diabetes and patients with early Alzheimer's

Disease

Insulin-aspart EudraCT2008-008555-41 (European

Clinical Trials Database), U1111-1122-

0680 (World Health Organisation), 10-

4463 (Ethik-Kommission der

Medizinischen Fakultat der Universitat

Duisburg-Essen), 4037292 (Federal

Institute for Drugs and Medical

Devices), 700206002 (Clinical Trials

Insight), DRKS00003133 (German

II Recruiting

Avineuro PharmaceuticalsRecruiting 22 Jun 2009 (actual)148 Clinical Trials Insight: 700053361 AVN-397 700053361 (Clinical Trials Insight)II

Synthetic BiologicsRecruiting placebo comparison 07 Jan 2008 (actual)

144

Clinical Trials Insight: 700030781 Tetrathiomolybdate 700030781 (Clinical Trials Insight)II

Cerebral blood flow Biovail Corporation, Cortex Pharmaceuticals140

Clinical Trials Insight: 700007433 CX-717 700007433 (Clinical Trials Insight)II Recruiting


139

Carvedilol as a potential novel disease modifying

agent for the treatment of Alzheimer's disease

Carvedilol 700048224 (Clinical Trials Insight)II

25 Jun 2010 (actual) 25 Sep 2012 (planned)

138

Assessment of association efficacy of colinergic

precursor and cholinesterasic inhibitor

somministered transdermal in patient with

Alzheimer`s disease and severe behavioural

disturbances




II Recruiting

II Not yet recruiting 01 Sep 2010 (planned) 01 Apr 2011 (planned)

Recruiting baseline comparison 29 Jul 2013 (actual) Prana Biotechnology

137

An Open-label, Three-period, Crossover Study in

Healthy Volunteers to Evaluate the Relative

Bioavailability of Two Different Release Rate

Controlled Release Formulations of Huperzine A

(0.4mg)Compared to the Equivalent Dose of an

Immediate Release Formulation.

Huperzine-A 700056729 (Clinical Trials Insight),

HUPA-HU1, NCT01136551



136

An Open Label Extension Study to Assess the

Safety and Tolerability of PBT2, and its Effect on

Amyloid Deposition in the Brains of Patients with

Prodromal or Mild Alzheimer's Disease.

[Extension of 700196942].

PBT-2 364492 (Australian New Zealand






Registry), PBT2-204Ext (Prana

Biotechnology)

II

Recruiting placebo comparison 01 Sep 2011 (actual) 01 Sep 2012 (planned)

Active, no longer recruiting 01 Aug 2011 (actual) 01 Sep 2013 (planned) VIVUS

135

A Trial of Memantine as Symptomatic Treatment

for Early Huntington Disease; a Phase IIb Study


H11-01346, NCT01458470



II

134

A Randomized, Placebo-Controlled, Double-Blind,

Crossover Study to Evaluate the Safety,

Tolerability and Efficacy of VI-1121 in Subjects


VI-1121 700206046 (Clinical Trials Insight),

AD201 (VIVUS), NCT01428362



II

Not yet recruiting 01 Jun 2009 (planned)

133

A randomized, double-blind, placebo-controlled,

parallel groups, study to evaluate the safety,

efficacy, pharmacokinetics and

pharmacodynamics of bryostatin 1 in patients

with mild to moderate Alzheimer's disease

Bryostatin-1 700031053 (Clinical Trials Insight),

BRY201 (Blanchette Rockefeller

Neurosciences Institute),



II

II Recruiting baseline comparison 01 Sep 2012 (actual) 01 May 2014 (planned) Abbott Laboratories, AbbVie

132

A Randomized, Double-Blind, Placebo-Controlled

Study to Evaluate the Efficacy and Safety of ABT-

126 in Subjects with Mild-to-Moderate

Alzheimer's Disease on Stable Doses

[EXTENSION of 700214516].

ABT-126 12803 (United Kingdom Clinical








M11-428 (Abbott), M11-428 (AbbVie

Deutschland GmbH and Co. KG),


01 Mar 2012 (actual) 01 Nov 2013 (planned) Abbott Laboratories, AbbVie

131

A Randomized, Double-Blind, Placebo-Controlled

Study to Evaluate the Efficacy and Safety of ABT-

126 in Subjects With Mild to Moderate

Alzheimer's Disease on Stable Doses of

Acetylcholinesterase Inhibitors.








Clinical Trials Database), M11-793

(Abbott Laboratories), M11-793

(AbbVie), NCT01549834




14 Feb 2012 (actual) 01 Nov 2013 (planned) Abbott Laboratories, AbbVie

130

A Randomized, Double-Blind, Placebo- and Active-

Controlled Phase 2 Dose-Ranging Study to

Evaluate the Efficacy and Safety of ABT-126 in

Subjects with Mild to Moderate Alzheimer's

Disease.




(Clinical Trials Insight), Dendron073




Clinical Trials Database), M10-985

(Abbott), M10-985 (AbbVie

Deutschland), NCT01527916




Active, no longer recruiting 01 Jul 2011 (actual) 01 Jan 2014 (planned) Genentech, Roche

129



Evaluate the Impact of MABT5102A on Brain

Amyloid Load and Related Biomarkers in Patients

With Mild to Moderate Alzheimer's Disease

Crenezumab 700202954 (Clinical Trials Insight),


ABE4955g (Genentech), EudraCT2010-


Database), GN00762 (Genentech),



II

prospective Magnetic resonance imaging outcomes

randomised Protein levels



Alzheimer's Disease Assessment Scale Cerebral-blood-flow

Assessment scale scores

Cerebral blood flow



double-blind baseline comparison Activities of Daily Living Scale Amyloid-levels

parallel drug + nondrug vs nondrug comparison Amyloid levels Apolipoprotein-E-level

prospective placebo comparison Apolipoprotein E level Biomarker-levels

randomised Assessment scale scores Brain-derived-neurotrophic-factor-levels

Biomarker levels C-reactive-protein

Brain derived neurotrophic factor levels Interleukin-1-levels

C reactive protein Interleukin-6-levels

Cognitive function Osteopontin-levels

Interleukin 1 levels Tumour-necrosis-factor-alpha-levels

Interleukin 6 levels Vascular-cell-adhesion-molecule-1-levels


Osteopontin levels


Tumour necrosis factor alpha levels [CONT.]

double-blind baseline comparison Drug concentration Pharmacokinetic-parameters

prospective drug formulation comparison Pharmacokinetic parameters

placebo comparison

double-blind baseline comparison Alzheimer's Disease Assessment Scale Cognitive-function-tests

parallel placebo comparison Amyloid levels Disease-progression




Disease progression

Tau levels

double-blind baseline comparison Cognitive function tests Sleep-efficiency

parallel placebo comparison Duration of hospitalisation Sleep-measures

prospective Patient compliance

randomised Sleep efficiency

Sleep measures

Symptoms

crossover Alzheimer's Disease Assessment Scale Magnetic-resonance-imaging-outcomes

double-blind Magnetic resonance imaging outcomes

randomised Response

Choline-alfoscerate double-blind Alzheimer's Disease Assessment Scale cognitive

subpart


Donepezil parallel Bristol Activities of Daily Living Scale Geriatric-Depression-Scale

prospective Geriatric Depression Scale Mini-Mental-State-Examination

randomised Instrumental Activities of Daily Living Scale Neuropsychiatric-Inventory

Mini Mental State Examination Trail-Making-Test-Part-A

Neuropsychiatric Inventory Trail-Making-Test-Part-B



Doxycycline double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

Rifampicin multicentre drug combination comparison Amyloid levels Clinical-Dementia-Rating



Cytokine levels


Interleukin 10 levels


Matrix metalloproteinase levels

Tau levels

Tumour necrosis factor alpha levels


subpart


multicentre drug dosage comparison Assessment scale scores

parallel placebo comparison Pharmacokinetic parameters

prospective

randomised


subpart


S-38093 multicentre drug dosage comparison Clinical response Clinical-response

parallel placebo comparison Disability Assessment for Dementia

prospective Pharmacokinetic parameters

randomised

Dronabinol double-blind baseline comparison Barthel Index Neuropsychiatric-Inventory

Paracetamol multicentre drug combination comparison Clinical Global Impressions scale


prospective Cohen Mansfield Agitation Inventory

randomised ECG changes


Pain intensity

Paired Associates Learning

Patient assessment of pain


Verbal rating scale

Vital signs

Wechsler Memory Scale


randomised placebo comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living InventoryCaregiver assessment


PlusMini Mental State Examination

multicentre

prospective

Arginine open Cerebral blood flow Cerebral-blood-flow

Sapropterin prospective Cognitive function tests

Simvastatin Magnetic resonance imaging outcomes

prospective baseline comparison Cognitive function tests Cognitive-function-tests

randomised untreated control group comparison Magnetic resonance imaging outcomes

166

Estrogen use in protection from cognitive decline Estradiol-congeners 700011926 (Clinical Trials Insight),

79324 (Stanford University), IA0063

(National Institute on Aging),






II Active, no longer recruiting 01 Aug 2003 (actual) 01 Dec 2014 (planned)

Neurokine Pharmaceuticals

165

Endothelial Facilitation in Alzheimer's Disease. An

Open Label Pilot Study of the Sequential and

Cumulative Effects of Simvastatin, L-Arginine,

and Sapropterin (Kuvan) on Cerebral Blood Flow

and Cognitive Function in Patients With


13748 (University of Massachusetts,

Worcester), 700206925 (Clinical Trials




II Recruiting baseline comparison 01 Nov 2011 (actual) 01 Jan 2014 (planned)

Not yet recruiting placebo comparison

Recruiting 01 May 2010 (actual) 01 Dec 2012 (planned)

164

Efficacy of NK 001 [etanercept] for the

prevention of Alzheimer's related cognitive

impairment in patients undergoing coronary

artery bypass surgery.

Etanercept 700194015 (Clinical Trials Insight)II

163

Efficacy and Safety of Tamibarotene (OAM80) for


Tamibarotene 700056208 (Clinical Trials Insight),


National Institutes of Health), OAM80-

01

II

16 May 2012 (actual) 01 Dec 2013 (planned) Echo Pharmaceuticals

162

Efficacy and safety of delta-9-

tetrahydrocannabinol (delta-THC) in pain and

pain related behavioural disturbances in

dementia.



Clinical Trials Database), GER001-02-

02 (Radboud University Nijmegen

Medical Centre), NCT01608217


Institutes of Health), NL38617-091-12

(Centrale Commissie Mensgebonden

Onderzoek)

II Recruiting

Recruiting 06 Sep 2012 (actual) 06 Feb 2015 (planned) IRIS, Servier

22 Aug 2011 (actual) 30 Apr 2014 (planned) Servier

161

Efficacy and safety of 3 doses of S 38093 (2, 5

and 20 mg/day) versus placebo, in co-

administration with donepezil (10 mg/day) in

patients with moderate Alzheimer's Disease. A 24-

week international, multi-centre, randomised,

double-blind, placebo-controlled phase IIb study

[Eficacia y seguridad de 3 dosis de S38093 (2, 5

y 20 mg/dia)frente a placebo, asociado a

donepezilo (10 mg/dia) en pacientes con

enfermedad de Alzheimer moderada [CONT.]



(Clinical Trials Insight), CL2-38093-012

(Institut de Recherches Internationales

Servier), EudraCT2011-005862-40


II

160

Efficacy and safety of 3 doses of S 38093 (2, 5

and 20 mg/day) versus placebo in patients with

mild to moderate Alzheimer's disease. A 24-

week international, multi-centre, randomised,

double-blind, placebo-controlled phase IIb study

followed by a 24-week extension period

S-38093 CL2-38093-011 (Institut de Recherches

Internationales Servier), EudraCT2010-


Database), 700203727 (Clinical Trials

Insight), 89039808 (ISRCTN: Current

Controlled Trials)

II Recruiting

01 Feb 2007 (actual) 01 Dec 2010 (planned)



Clinical Trials Database), KUH5772749

(Kuopio University Hospital),



II

Recruiting 01 Dec 2008 (actual) 01 Jun 2013 (planned)

156

Does Zolpidem CR Treatment Change Clinical

Outcomes in Elderly Hospitalized Patients With

Dementia- A Pilot Study.

Zolpidem 2008P001434-1 (Massachusetts

General Hospital), 700040900 (Clinical




II

159

Effects of Treatment With Doxycycline and

Rifampicin on Biomarkers of Alzheimer's Disease

in the Cerebrospinal Fluid.



National Institutes of Health), PSI06-47


drug combination comparison 25 Jun 2009 (actual) 25 Dec 2011 (planned)

158

Effect of the association between an inhibitor of

cholinesterase and the cholinergic precursor

choline alfoscerate on cognitive symptoms of

Alzheimer's disease associated with vascular

damage [Effetto dellassociazione tra un inibitore

delle colinesterasi ed il precursore colinergico

colina alfoscerato sui sintomi cognitivi e non della

malattia di Alzheimer con danno vascolare

associato]


DEM-AsCol08-01 (AZIENDA

OSPEDALIERA CARDARELLI),



II Recruiting

Not yet recruiting 21 Feb 2013 (planned) 21 Feb 2014 (planned)

155

Disease-modifying Properties of Lithium in the

Neurobiology of Alzheimer's Disease: a Double-

blind, Placebo-controlled Prevention Study in

Elderly Patients With Mild Cognitive Impairment.

Lithium

Active, no longer recruiting placebo comparison 01 Mar 2007 (actual) 01 Oct 2008 (planned)

157

Effect of rivastigmine on FMRI [functional

magnetic resonance imaging] in mild Alzheimer's

disease

Rivastigmine

554535-2005-0, 700053175 (Clinical




154

DEVELOPMENT OF NEW FORMULATION OF

BACOPA MONNIERA TO IMPROVE ITS

PHARMACOKINETIC PROPERTIES

Bacopa-monnieri 700230253 (Clinical Trials Insight),

CTRI2013-02-003414 (Clinical Trials

Registry - India)

II

II Not yet recruiting 01 Mar 2013 (planned) 01 Dec 2016 (planned)

prospective baseline comparison 01 Feb 2008 (actual) 01 Dec 2010 (planned)

153

Curcumin and Yoga Exercise Effects in Veterans

at Risk for Alzheimers Disease

Curcumin 700230720 (Clinical Trials Insight),

E0669I (Department of Veterans

Affairs), NCT01811381


Institutes of Health), VA-RX00069

(Department of Veterans Affairs)

II Active, no longer recruiting 01 Mar 2007 (actual) 01 Mar 2009 (planned)

26 May 2011 (actual)

152

Continuous arterial spin labeling (CASL) MRI

[magnetic resonance imaging] for monitoring

and prediction of drug therapy in Alzheimers

Disease (AD).


C1073-14 (Corcept Therapeutics),

CASL-AD01 (University Hospital Bonn),




151

Comparative study on the effect of intranasal

insulin on cognitive function in patients with type

2 diabetes and patients with early Alzheimer's

Disease

Insulin-aspart EudraCT2008-008555-41 (European

Clinical Trials Database), U1111-1122-

0680 (World Health Organisation), 10-

4463 (Ethik-Kommission der

Medizinischen Fakultat der Universitat

Duisburg-Essen), 4037292 (Federal

Institute for Drugs and Medical

Devices), 700206002 (Clinical Trials

Insight), DRKS00003133 (German

II Recruiting


double-blind baseline comparison Alzheimer's Disease Assessment Scale Glucose-level


prospective Glucose level

randomised Magnetic resonance imaging outcomes

open Amyloid levels Cognitive-function

prospective Clinical Global Impressions scale Glucose-level

Clinical improvement Mini-Mental-State-Examination

Cognitive function

Glucose level



Quality of life rating scales


prospective Positron emission tomography imaging outcomes Positron-emission-tomography-imaging-outcomes

Wechsler Memory Scale Wechsler-Memory-Scale

double-blind baseline comparison Biomarker levels Biomarker-levels

parallel placebo comparison Cognitive function tests Positron-emission-tomography-imaging-outcomes

prospective Glutamate levels



observational Assessment scale scores Clinical-Global-Impressions-scale

prospective Caregiver assessment


double-blind Amyloid levels


Disease occurrence

double-blind Activities of Daily Living Scale Neuropsychological-Test-Battery

multicentre Biomarker levels

parallel Cognitive function

prospective Disease progression rate


Montgomery Asberg Depression Rating Scale


multicentre Columbia Suicide Severity Rating Scale Columbia-Suicide-Severity-Rating-Scale

open Cornell Scale for Depression in Dementia Cornell-Scale-for-Depression-in-Dementia

prospective


multicentre placebo comparison Cognitive function tests

parallel Pharmacokinetic parameters

randomised

open baseline comparison Brain volume Brain-volume

parallel placebo comparison Magnetic resonance imaging outcomes Magnetic-resonance-imaging-outcomes

prospective Protein levels Protein-levels

randomised

Mecamylamine crossover drug comparison Assessment scale scores Assessment-scale-scores

Nicotine double-blind placebo comparison Cognitive function tests Cognitive-function-tests

multicentre Magnetic resonance imaging outcomes Magnetic-resonance-imaging-outcomes

randomised Profile of Mood States

observational Alzheimer's Disease Assessment Scale cognitive

subpart

Bodyweight

open Amyloid levels Haematological-response

prospective Biomarker levels Laboratory-parameters

Bodyweight

Cognitive function


Haematological response






Tau levels

open Activities of Daily Living Scale Cognitive-function-tests

prospective Biomarker levels Cognitive-function

single-blind Cognitive function Hamilton-Depression-Rating-Scale

Cognitive function tests Neurological-parameters

Hamilton Depression Rating Scale Positive-and-Negative-Syndrome-Scale

Motor function Vital-signs


Positive and Negative Syndrome Scale

Quality of life

Vital signs

parallel Computerised tomography changes Pharmacokinetic-parameters


single-blind

181Phase II proof-of-concept trial of SUVN 502 in

patients with cognitive dysfunction.

SUVN-502 II Planning prospective Pharmacokinetic parameters 01 Dec 2011 (planned) Suven Life Sciences 700047467 (Clinical Trials Insight)


subpart



of Daily Living Inventoryparallel placebo comparison Apolipoprotein E level

prospective Clinician Administered Dissociative States Scale


Tau levels

183Phase II study of TC 5619 in patients with


TC-5619 II Planning prospective Clinical response 01 Dec 2011 (planned) Targacept 700198136 (Clinical Trials Insight)


subpart

Biomarker-levels




parallel Apolipoprotein E level Tau-levels

prospective Biomarker levels

randomised Brain volume


Clinical response rate

Cognitive function

Glycaemic control

Insulin levels




Neuropsychiatric Inventory [CONT.]

185Phase II trial of AVN 211 in patients with

Alzheimer's disease

AVN-211 II Planning prospective Avineuro Pharmaceuticals 700235083 (Clinical Trials Insight)

186Phase II trial of AVN-101 for treatment of


AVN-101 II Recruiting prospective 01 Jun 2009 (planned) Avineuro Pharmaceuticals 700043298 (Clinical Trials Insight)

01 May 2012 (actual) 01 Sep 2015 (planned)

184

Phase II Study to Evaluate the Impact on

Biomarkers of Resveratrol Treatment in Patients


Resveratrol 700213145 (Clinical Trials Insight),

ADC037RES (Alzheimer's Disease

Cooperative Study), NCT01504854




01 Oct 2011 (actual) 01 Jul 2013 (planned) Shanghai Green Valley Pharmaceutical

182

Phase II Study of Sodium Oligo-mannurarate

Capsule on Mild to Moderate Alzheimer Disease.

Sodium-oligomannurarate 700208550 (Clinical Trials Insight),

9712011-1, NCT01453569




Recruiting drug dosage comparison 01 Dec 2010 (actual)180

PET microdose study of donepezi in humans. Donepezil 700192811 (Clinical Trials Insight),



II

II Recruiting baseline comparison 30 Jun 2008 (actual) 02 Mar 2010 (planned)

179

Open-label phase IIa pilot study exploring safety

and potential efficacy of recombinant human

erythropoietin in early mild Alzheimer Dementia

and therapy-refractory Major Depression

("EPO-AD")

Recombinant-

erythropoietin


EPO-AD01-2008 (Max-Planck-Institute

of Experimental Medicine),



Recruiting baseline comparison 30 Oct 2012 (actual) 30 Oct 2015 (planned) Velacor Therapeutics

178

Open Label Extension Study to Evaluate the

Safety, Tolerability and Cognitive Effects of

VEL015 (Sodium Selenate) in Patients with

Alzheimer's Disease

Sodium-selenate 363494 (Australian New Zealand






Registry), Velacor002E1

II

01 Oct 2010 (planned) 01 Oct 2012 (planned)

01 Sep 2011 (actual) 01 Nov 2012 (planned)

177

Nicotinic Modulation of the Default Network of

Resting Brain Function.


HP00042696, NCT01223404


Institutes of Health), R21DA027894

(National Institute on Drug Abuse)


176

MRI and MRS Diagnosis and Treatment

Monitoring of Alzheimer's Disease With Novel

Therapy.

Minocycline 700209069 (Clinical Trials Insight),

LKW-AB34 (Huntington Medical

Research Institutes), NCT01463384


II Recruiting

Active, no longer recruiting 01 May 2006 (actual) 01 Mar 2008 (planned) Eli Lilly

01 Aug 2012 (actual) 01 May 2014 (planned) Abbott Laboratories, AbbVie

175

LY2062430: Multiple-dose safety in subjects with

mild-to-moderate Alzheimer's disease and single-

dose safety in healthy volunteers

Solanezumab 6649 (Eli Lilly), 700013584 (Clinical

Trials Insight), H8A-MC-LZAJ (Eli Lilly

Secondary Identifier), NCT00329082


II

Nutricia

174

Long-Term Safety and Tolerability of ABT-126 in

Subjects With Mild-to-Moderate Alzheimer's

Disease: An Open-Label Extension Study for

Subjects Completing Study M10-985

[EXTENSION OF 700213283]

ABT-126 12125 (United Kingdom Clinical








M11-427 (Abbott), NCT01676935

II Recruiting baseline comparison

Genentech

173

LipiDiDiet study: efficacy of Souvenaid in the

prevention of Alzheimer's disease

Nutrient-formulae 700221971 (Clinical Trials Insight)II Recruiting control group comparison 01 Dec 2009 (actual)

II Not yet recruiting placebo comparison 31 Mar 2013 (planned)

Recruiting baseline comparison 30 May 2013 (actual)

172

Landmark clinical trial of crenezumab for the

prevention of Alzheimer's disease in healthy

subjects who are genetically predisposed to

developing the disease.

Crenezumab 700217666 (Clinical Trials Insight)

171

Investigation on efficacy and safety of

rivastigmin patch in patients switched from

donepezil with mild to moderate Alzheimer's

disease




II

II Recruiting 01 Apr 2013 (actual) 01 Nov 2017 (planned)

Active, no longer recruiting baseline comparison 01 Jan 2012 (actual)

170

Glutamatergic Dysfunction in Cognitive Aging:

Riluzole in Mild Alzheimer's Disease

Riluzole 700224326 (Clinical Trials Insight),

APE0792 (The Rockefeller University),



169

Evaluation of effect of cilostazol on cerebral

glucose metabolism in patients with amnestic

mild cognitive impairment and preclinical

Alzheimer's disease with lacunar infarction.

Cilostazol 700208838 (Clinical Trials Insight),



II

01 Jan 2015 (planned) Louisiana State University Health Sciences Center

168

Evaluating the Efficacy of Controlled Pulsatile

Intravenous Insulin on Cognition and Amyloid

Burden in Patients With Alzheimer's Disease- A

Pilot Study.

Insulin-lispro 700220258 (Clinical Trials Insight),

H12-166 (Louisiana State University

Health Sciences Center), NCT01636596



II Not yet recruiting baseline comparison 01 Sep 2013 (planned)

167

Evaluating the Effects of the Novel GLP-1

Analogue, Liraglutide, in Patients With Mild

Alzheimer's Disease (ELAD Study)

Liraglutide 700232410 (Clinical Trials Insight),


National Institutes of Health), U1111-

1131-9252 (World Health

II Not yet recruiting 01 Jun 2013 (planned) 01 Jun 2016 (planned)

166

Estrogen use in protection from cognitive decline Estradiol-congeners 700011926 (Clinical Trials Insight),

79324 (Stanford University), IA0063

(National Institute on Aging),






II Active, no longer recruiting 01 Aug 2003 (actual) 01 Dec 2014 (planned)

188Phase II trial of indolepropionic acid in patients

with Alzheimer's disease.

Indolepropionic-acid II Planning prospective baseline comparison 01 Dec 2009 (planned) Intellect Neurosciences 700039543 (Clinical Trials Insight)

double-blind baseline comparison Activities of Daily Living Scale Alzheimer's-Disease-Assessment-Scale Met

multicentre placebo comparison Alzheimer's Disease Assessment Scale

randomised Clinical Global Impressions scale



Quality of life

190Phase II trial of methanesulfonyl fluoride for the

treatment of Alzheimer's disease.

Methanesulfonyl-fluoride II Planning prospective SeneXta Therapeutics 700193170 (Clinical Trials Insight)

191Phase II trial of MK 8931 in patients with


MK-8931 II Planning prospective Merck 700209597 (Clinical Trials Insight)

192Phase II trial of RVX-208 in patients with mild

cognitive impairment

RVX-208 II Planning prospective baseline comparison 01 Jun 2013 (planned) Resverlogix Corporation 700231339 (Clinical Trials Insight)

193

Phase IIa trial of BLU 8499 in the treatment of

mild Alzheimer's disease in patients with an

apoE4 positive genotype.

Tramiprosate II Planning prospective 01 Dec 2014 (planned) Asclepios Bioresearch (UK), BELLUS Health 700222615 (Clinical Trials Insight)

194Phase IIb trial of NIC5-15 in patients with


NIC-515 II Recruiting prospective baseline comparison Disease progression Humanetics Corporation 700219591 (Clinical Trials Insight)

double-blind baseline comparison Alzheimer's Disease Assessment Scale Cognitive-function-tests

randomised drug dosage comparison Cognitive function tests

placebo comparison

double-blind baseline comparison


prospective

randomised

Piracetam double-blind baseline comparison

Rivastigmine multicentre drug combination comparison

parallel drug comparison


randomised

198

Planned phase II proof-of-concept trial of

allopregnanolone in patients with Alzheimer's

disease.

Allopregnanolone II Planning prospective 700234875 (Clinical Trials Insight)

199Planned phase II trial of PQ 912 in patients with


PQ-912 II Planning prospective Probiodrug 700234919 (Clinical Trials Insight)

200 Planned phase II trial of sGC 1061. SGC-1061 II Planning prospective sGC Pharma 700234561 (Clinical Trials Insight)

201

Planned phase II trials of SYN 120 for cognition

disorders associated with Alzheimer's disease

and schizophrenia

SYN-120 II Planning prospective Biotie Therapies Corp., Roche 700197379 (Clinical Trials Insight),


202

Proof-of-concept phase IIa trial of FGLS in

patients with Alzheimer's disease.

FGLS II Planning prospective ENKAM Pharmaceuticals A/S 700210927 (Clinical Trials Insight),



700210933 (Clinical Trials Insight)double-blind baseline comparison Blood pressure Brain-volume


parallel Cerebral blood flow



Disease progression rate


Patient compliance

Quality of life


parallel drug dosage comparison Pharmacokinetic parameters


randomised subject comparison

open Cognitive function tests Cognitive-function-tests

prospective Glucose level

Oxidative stress markers

Crocus double-blind Alzheimer's Disease Assessment Scale cognitive

subpart


Donepezil parallel Clinical Dementia Rating Symptom-severity

randomised Symptom severity


parallel placebo comparison Magnetic resonance imaging outcomes

randomised

Insulin double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Cognitive-function

Insulin-detemir multicentre drug comparison Amyloid levels

parallel placebo comparison Apolipoprotein E level

prospective Benton Visual Retention test

randomised Blood flow


Cognitive function

Gene expression

Oral glucose tolerance test

Tau levels

prospective Assessment scale scores Cohen-Mansfield-Agitation-Inventory

single-blind Cohen Mansfield Agitation Inventory


Resource use


subpart

Computerised-tomography-imaging-outcomes

prospective Behaviour scale scores Magnetic-resonance-imaging-outcomes

Cognitive function tests Near-infrared-spectroscopy-outcomes





Near infrared spectroscopy outcomes




subpart


prospective Assessment scale scores

Behaviour scale scores








subpart

Neurological-parameters

prospective Assessment scale scores

Behaviour assessment

Cognitive function









211

The efficacy and response of switching from

donepezil to galantamine in Alzheimer disease:

multi-modal neuroimaging analysis (structural

and functional neuroimaging) of open-label,

clinical trial





The efficacy and response of donepezil in severe

Alzheimer disease: multi-modal neuroimaging

analysis (structural and functional neuroimaging)

of open-label, clinical trial




II Recruiting

209

The Effect of Memantine on Aggression and

Agitation and Its Impact on Caregiver Burden of

Patients With Alzheimer's Disease: A 12-week

Open-label Study

Memantine 700035372 (Clinical Trials Insight), CN-

IIT12292 (Peking University),



II Recruiting

baseline comparison 24 Apr 2013 (actual)

10 Dec 2012 (actual) 30 Mar 2015 (planned)

212


either donepezil or galantamine to rivastigmine

transdermal patch in Alzheimer disease: multi-

modal neuroimaging analysis (structural and

functional neuroimaging) of open-label, clinical

trial

Rivastigmine

01 Nov 2011 (actual) 01 Mar 2013 (planned)

Recruiting 01 Mar 2009 (actual) 01 Feb 2012 (planned)

208

Study of Nasal Insulin to Fight Forgetfulness -

Long-acting Insulin Detemir - 120 Days

39885A (University of Washington),



National Institutes of Health), ZEN10-

173646US (Alzheimer's Association)


207

Statin Effects on Beta-Amyloid and Cerebral

Perfusion in Adults at Risk for AD: "Statins

in Healthy, At-Risk Adults: Impact on Amyloid

and Regional Perfusion (SHARP)" Study.

Simvastatin 700047115 (Clinical Trials Insight),

H2009-0030 (University of Wisconsin),



II

17 Dec 2012 (actual) 30 Mar 2015 (planned)

01 Mar 2008 (actual) 01 Jun 2014 (planned) Lundbeck A/S

210

Active, no longer recruiting drug comparison 10 Nov 2006 (actual)

Recruiting baseline comparison 01 Jul 2011 (actual) 01 Apr 2014 (planned)

206

Saffron extract in the treatment of mild to

moderate Alzheimer's disease: A double blind

randomized controlled trial.




II

Recruiting 01 Nov 2012 (actual) 01 Sep 2013 (planned) EnVivo Pharmaceuticals

205

Safety/Tolerability and Effects on Cognitive

Impairment, Impaired Cerebral Cortical

Metabolism and Oxidative Stress of

R(+)Pramipexole Administered to Subjects With

Early Alzheimer's Disease

Pramipexole 20101202, 700202109 (Clinical Trials



Institutes of Health), VCU-KU-

ADDF2011 (Virginia Commonwealth

II

Recruiting 04 Jul 2013 (actual) 07 Jun 2017 (planned)

204

Safety, Tolerability, Pharmacokinetics, and

Effects of EVP-0962 on Cerebral Spinal Fluid

Amyloid Concentrations in Healthy Subjects and

in Subjects With Mild Cognitive Impairment or

Early Alzheimer's Disease

EVP-0962 700221858 (Clinical Trials Insight),

EVP0962-002 (EnVivo

Pharmaceuticals), NCT01661673



II

203

Reducing pathology in Alzheimer's Disease

through Angiotensin taRgeting. The RADAR Trial.

A phase II, two arm, double-blind, placebo-

controlled, randomised trial to evaluate the effect

of losartan on brain tissue changes in patients

diagnosed with Alzheimer's disease.

Losartan 2625 (North Bristol NHS Trust),




II

Mini Mental State Examination 21 Mar 2009 (actual)

197

Piracetam, Rivastigmine and their joint

consumption effects on Mini Mental Status

Examination in patients with Alzheimer's disease





Recruiting Cognitive function tests 01 Mar 2011 (actual) 01 Jan 2014 (planned)

Prana Biotechnology

196

Pilot Phase 2 Trial of the Safety & Efficacy of GM-

CSF (Leukine) in the Treatment of Alzheimer's

Disease

Sargramostim 700204240 (Clinical Trials Insight),



Pro00002098

II

195

Phase IIb trial of PBT 2 in patients with mild-to-

moderate Alzheimer's disease

PBT-2 700046754 (Clinical Trials Insight)II Planning

Medivation

AstraZeneca, Targacept

189

Phase II trial of latrepidine in patients with mild-

to-moderate Alzheimer's disease.

Latrepirdine 700190812 (Clinical Trials Insight)II Active, no longer recruiting

Planning prospective187

Phase II trial of AZD 1446 as an adjunctive

treatment to donepezil in patients with mild to

moderate Alzheimer's disease.

AZD-1446 700211880 (Clinical Trials Insight)II





multicentre baseline comparison Bristol Activities of Daily Living Scale Bristol-Activities-of-Daily-Living-Scale

prospective drug dosage comparison Mini Mental State Examination Mini-Mental-State-Examination


Galantamine crossover baseline comparison Cognitive function tests Cognitive-function-tests

Levodopa parallel drug comparison Reaction time Reaction-time

prospective placebo comparison Working memory Working-memory

randomised subject comparison

single-blind

crossover Assessment scale scores Neuropsychiatric-Inventory

double-blind Cohen Mansfield Agitation Inventory

multicentre Delirium Rating Scale

prospective Gene expression

randomised Neurological parameters




216Zinc monocysteine in elderly patients with mild to


Zinc-monocysteine II Planning prospective Synthetic Biologics 700204915 (Clinical Trials Insight)

double-blind baseline comparison Activities of Daily Living Scale Antibody-levels

multicentre placebo comparison Alzheimer's Disease Assessment Scale Biochemical-response

parallel Alzheimer's Disease Assessment Scale cognitive

subpart

Cognitive-function-tests

prospective Amyloid levels ECG-changes

randomised Antibody levels Haematological-response

Biochemical response Immunoglobulin-G-levels

Biomarker levels Immunological-response

Brain volume Inflammatory-markers

Clinical Dementia Rating Magnetic-resonance-imaging-outcomes

Clinical response Neurological-parameters

Cognitive function tests Neuropsychological-Test-Battery

Disability Assessment for Dementia Urinalysis

Disease progression Vital-signs

ECG changes

Global Assessment of Functioning

Haematological response [CONT.]

double-blind drug dosage comparison Assessment scale scores

multicentre placebo comparison Caregiver assessment

parallel subject comparison Clinical response rate

prospective Electrophysiological measures



open baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpartprospective drug formulation comparison Mini Mental State Examination

220

Efficacy of Donepezil in Normalizing Brain

Activation Patterns in People Genetically at Risk

for Alzheimer's Disease.

Donepezil I/II Recruiting prospective baseline comparison Magnetic resonance imaging outcomes Magnetic-resonance-imaging-outcomes 01 Dec 2006 (actual) 01 Dec 2010 (planned) 040686, 700019820 (Clinical Trials



Institutes of Health)double-blind baseline comparison Alzheimer's Disease Assessment Scale Alzheimer's-Disease-Assessment-Scale

parallel placebo comparison Caregiver assessment

prospective Tau levels

randomised

Omega-3-fatty-acids double-blind baseline comparison Activities of Daily Living Scale Activities-of-Daily-Living-Scale

Thioctic-acid parallel drug combination comparison Alzheimer's Disease Assessment Scale cognitive

subpart



randomised

open Alzheimer's-Disease-Assessment-Scale-cognitive-subpart

prospective

Climacteric symptoms Maximum-tolerated-dose


Maximum tolerated dose


multicentre baseline comparison Assessment scale scores

prospective drug dosage comparison Biomarker levels

randomised placebo comparison Drug bioavailability




Omega-3-fatty-acid double-blind baseline comparison Brain volume Trail-Making-Test-Part-B

Thioctic-acid parallel placebo comparison Patient compliance

prospective Trail Making Test Part B

randomised

double-blind baseline comparison Biomarker levels



randomised Symptoms

Aluminium-hydroxide double-blind baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpartAlzheimer's-disease- multicentre placebo comparison Antibody levels

parallel Controlled Oral Word Association Test

prospective Immunological response rate

randomised Letter and Category Fluency


parallel drug dosage comparison Area under the drug concentration time curve

prospective placebo comparison Drug half life

randomised Maximum tolerated dose



double-blind baseline comparison Amyloid levels Maximum-tolerated-dose

parallel drug dosage comparison Area under the drug concentration time curve

prospective placebo comparison Elimination rate constant

randomised Maximum tolerated dose



double-blind baseline comparison

multicentre drug dosage comparison


randomised


subpart

Drug-concentration

multicentre drug dosage comparison Amyloid levels Pharmacokinetic-parameters

parallel placebo comparison Drug concentration

prospective Mini Mental State Examination


Tau levels

double-blind placebo comparison Area under the drug concentration time curve

multicentre route of administration comparison Coagulation parameters

parallel Drug terminal half life

prospective ECG changes

01 Jan 2012 (actual) 01 Oct 2014 (planned) Sanofi

233

A Multi-center, Parallel-group, Double-blind,

Placebo-controlled Single and Multiple Dose

Escalation Study to Assess the Safety and

Tolerability and the Pharmacokinetic Properties of

SAR228810 Given as IV Infusion or as SC

Injection in Patients With Mild to Moderate


SAR-228810 700210693 (Clinical Trials Insight),





TDR12399 (Sanofi-Aventis), U1111-


Organisation)

I Recruiting

Recruiting 01 Jun 2012 (actual) 01 Mar 2014 (planned) Chugai Pharmaceutical

232

A Multi-center, Multiple-ascending Dose,

Randomized, Double-blind, Placebo-controlled,

Parallel-group Study to Investigate the Safety,

Tolerability and Pharmacokinetics of RO4909832

Following Subcutaneous Injection in Japanese AD

Patients

Gantenerumab 700221497 (Clinical Trials Insight),

JapicCTI121849 (Chugai

Pharmaceutical), JP22431 (Chugai

Pharmaceutical), NCT01656525



I

Active, no longer recruiting Drug concentration 01 Oct 2011 (actual) 01 Sep 2012 (planned) TransTech Pharma

231

A Double-blind, Randomized, Placebo-controlled,

Phase 1 Study of 2 Escalating, Single

Subcutaneous Doses to Evaluate the Safety,

Tolerability, Immunogenicity, and

Pharmacokinetics of TTP4000 in Subjects With

Alzheimer's Disease With Mild Cognitive

Impairment

TTP-4000 700190904 (Clinical Trials Insight),


National Institutes of Health), TTP4000-

101 (TransTech Pharma)

I

I Recruiting 01 Mar 2013 (actual) 01 Jul 2013 (planned) Janssen Research & Development

Recruiting 01 May 2013 (actual) 01 Aug 2013 (planned) Janssen Research & Development

230

A Double-Blind, Placebo-Controlled, Randomized,

Single-Ascending Dose Study To Investigate the

Safety, Tolerability and Pharmacokinetics of JNJ-

54861911 in Healthy Subjects

JNJ-54861911 700231825 (Clinical Trials Insight),

CR101083 (Janssen Research and

Development), EudraCT2013-000215-




229

A Double-Blind, Placebo-Controlled, Randomized,

Multiple-Ascending Dose Study to Investigate the

Safety, Tolerability, Pharmacokinetics and

Pharmacodynamics of JNJ-54861911 in Healthy

Elderly Subjects

JNJ-54861911 700234395 (Clinical Trials Insight),

CR101620 (Janssen Research and

Development, LLC), EudraCT2013-





I

01 May 2013 (actual) 01 Mar 2015 (planned) Axon Neuroscience

228

A 3-months Randomized, Placebo-controlled,

Parallel Group, Double-blinded, Multi-centre,

Phase I Study to Assess Tolerability and Safety

of AADvac1 Applied to Patients With Mild-

Moderate Alzheimer's Disease With 3-months

Open Label Extension


AXON-CO18700 (Axon Neuroscience),



I Recruiting

I/II Recruiting 01 Apr 2012 (actual) Maruzen Pharmaceuticals

01 Apr 2013 (planned) 01 Mar 2015 (planned)

227

Safety and efficacy of rosmarinic acid in patients

with Alzheimer's disease: Double blind placebo-

controlled study.

Rosmarinic-acid 700216405 (Clinical Trials Insight),



226

Pilot Study: Lipoic Acid and Omega-3 Fatty Acid

for Alzheimer's Disease Prevention



National Institutes of Health), SFF01

(Oregon Health and Science University)

I/II Not yet recruiting

Not yet recruiting 16 Mar 2011 (actual) Anavex Life Sciences

225

Phase I/II trial of ANAVEX-2-73 in healthy

volunteers and patients with Alzheimer's disease.

ANAVEX-2-73 700049309 (Clinical Trials Insight)I/II

Recruiting prospective baseline comparison

224

Phase I/II study of tolerability and

pharmacokinetics of isoflavones (phyto-beta-

SERM) in women with menopausal syndrome

Isoflavones 700204056 (Clinical Trials Insight)I/II

Recruiting baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

01 Apr 2012 (actual) 01 Jan 2014 (planned)223

Open Label Study of Isotretinoin in Mild to


Isotretinoin 700215283 (Clinical Trials Insight),

ISOTRT01, NCT01560585


I/II

Recruiting 01 Sep 2010 (actual) 01 Jan 2015 (planned)

I/II Active, no longer recruiting 01 Jan 2008 (actual) 01 Jul 2012 (planned)

222

Lipoic Acid and Omega-3 Fatty Acids in



IRB00009346 (Oregon Health and

Science University Institutional Review

Board), NCT01058941


I/II

Recruiting Aphios Corporation

221

Efficacy of Nicotinamide for the Treatment of


Nicotinamide 700055152 (Clinical Trials Insight),

IIRG07-61197, NCT00580931



219A phase I/II trial of bryostatin 1 administered

intravenously in patients with Alzheimer's

disease.

Bryostatin-1 700212670 (Clinical Trials Insight)I/II

Recruiting 01 Jan 2012 (actual) 01 Feb 2014 (planned) Regenera Pharma

218

A Randomized Single and Multiple Dose Study

Evaluating the Safety and Tolerability of RPh201

in Healthy Subjects and in Adults With


RPh-201 700212560 (Clinical Trials Insight),


National Institutes of Health), RGN-

ADC001 (Regenera Pharma)

I/II

09 Dec 2009 (actual) 09 Dec 2012 (planned) AC Immune, Bayer HealthCare Pharmaceuticals

217

A Phase I/II Double-Blind, Randomised, Placebo-

Controlled, Adaptive Design Study of the Safety,

Tolerability, Immunogenicity and Efficacy of ACI-

24 in Patients with Mild to Moderate Alzheimer's

Disease

ACI-24 700050142 (Clinical Trials Insight),

ACI24-0701 (AC Immune SA),



I/II Recruiting





Recruiting placebo comparison 18 May 2011 (actual) 01 Mar 2014 (planned) Echo Pharmaceuticals

215

Two Phase, Repeated Crossover Study With Dose

Escalation on Delta(9)-Tetrahydrocannabinol

(Delta-THC) in Behavioral Disturbances in

Dementia.

Dronabinol 2009-019329, 700195367 (Clinical



GER001-02-01, NCT01302340



II

16 Nov 2009 (actual) 16 May 2010 (planned)

214

The role of the neurotransmitters dopamine and

acetylcholine in the interaction of selective

attention and working memory.

06173915 (Otto-von-Guericke

University), 700218295 (Clinical Trials

Insight), EudraCT2009-011093-15


II Recruiting

Recruiting 01 Jun 2013 (actual) 31 May 2018 (planned)

baseline comparison 24 Apr 2013 (actual)

213

The MADE Trial: Minocycline in Alzheimer's

Disease Efficacy trial

Minocycline 14866 (United Kingdom Clinical




II

212


either donepezil or galantamine to rivastigmine

transdermal patch in Alzheimer disease: multi-

modal neuroimaging analysis (structural and

functional neuroimaging) of open-label, clinical

trial

Rivastigmine




Vital signs

double-blind baseline comparison Area under the drug concentration time curve Biomarker-levels

multicentre drug dosage comparison Biomarker levels Tau-levels


prospective Drug concentration




Tau levels



subpart

parallel Clinical Dementia Rating

prospective Disability Assessment for Dementia



open drug regimen comparison Area under the drug concentration time curve

prospective site of administration comparison Drug half life

sequential Peak drug concentration


double-blind drug dosage comparison Alzheimer's Disease Assessment Scale Columbia-Suicide-Severity-Rating-Scale


subpart

ECG-changes

parallel Amyloid levels Laboratory-parameters

prospective Antibody levels Magnetic-resonance-imaging-outcomes

randomised Area under the drug concentration time curve Neurological-parameters

Assessment scale scores Pharmacokinetic-parameters

Biomarker levels Vital-signs


Columbia Suicide Severity Rating Scale

Disability Assessment for Dementia

Disability progression

Drug clearance

Drug concentration

Drug half life

ECG changes [CONT.]

double-blind baseline comparison Area under the drug concentration time curve Columbia-Suicide-Severity-Rating-Scale


prospective Columbia Suicide Severity Rating Scale

randomised Peak drug concentration



Trough drug concentration

double-blind baseline comparison Biomarker levels Columbia-Suicide-Severity-Rating-Scale

parallel placebo comparison Columbia Suicide Severity Rating Scale

prospective subject comparison Dose parameters



subpart

Drug-concentration

prospective drug dosage comparison Alzheimer's Disease Cooperative Study Activities

of Daily Living Inventoryrandomised placebo comparison Clinical Dementia Rating

Drug concentration





double-blind baseline comparison Antibody levels

multicentre placebo comparison Area under the drug concentration time curve

prospective Drug clearance

randomised Drug concentration

Drug half life



EVP-6124 crossover baseline comparison QT-interval

Moxifloxacin double-blind drug comparison


randomised



prospective Pharmacokinetic parameters

randomised

double-blind baseline comparison Drug concentration

parallel drug dosage comparison Drug metabolite concentration


randomised

double-blind baseline comparison Drug concentration ECG-changes

multicentre placebo comparison ECG changes Magnetic-resonance-imaging-outcomes

parallel Immunological response rate Vital-signs

prospective Magnetic resonance imaging outcomes

randomised Plaque volume


Vital signs

Ispronicline crossover Pharmacokinetic-parameters

Warfarin double-blind

randomised

double-blind baseline comparison Area under the drug concentration time curve

multicentre drug dosage comparison Peak drug concentration

open drug regimen comparison


prospective route of administration comparison

randomised

Recruiting 01 May 2013 (actual) 01 Mar 2015 (planned) Eli Lilly

247

A Single-Dose and Multiple-Dose, Dose-

Escalation Study to Evaluate the Safety,

Tolerability, and Pharmacokinetics of LY3002813

in Patients With Mild Cognitive Impairment Due

to Alzheimer's Disease or Mild to Moderate

Alzheimer's Disease

LY-3002813 15082 (Eli Lilly), 700232264 (Clinical

Trials Insight), I5T-MC-AACC (Eli Lilly

Secondary Identifier), NCT01837641



I

drug combination comparison Pharmacokinetic parameters 01 Sep 2007 (actual) 01 Feb 2009 (planned) AstraZeneca

246

A Single-Centre, Double Blind, Randomized, Two-

Way Cross-Over Study of Repeated Doses of

AZD3480 and Single Dose of Warfarin to

Evaluate the Pharmacokinetic Interaction of

AZD3480 and Warfarin and the Effect of

AZD3480 Pharmacodynamic in Healthy Male

Subjects (Phase I)


D3690C00014 (AstraZeneca),





I Recruiting

Recruiting 01 Oct 2012 (actual) 01 Apr 2016 (planned) Biogen Idec

245

A Randomized, Double-Blinded, Placebo-

Controlled Multiple Dose Study to Assess the

Safety, Tolerability, Pharmacokinetics, and

Pharmacodynamics of BIIB037 in Subjects With

Prodromal or Mild Alzheimer's Disease

BIIB-037 221AD103 (Biogen Idec), 700222669






I

BIIB-037 221AD101, 700197951 (Clinical Trials




I

Recruiting 11 Mar 2013 (actual) 31 Mar 2014 (planned) University of Tokyo

Recruiting 01 May 2012 (actual) 01 Nov 2013 (planned) Eisai Inc

244

A Randomized, Double-Blind, Placebo-Controlled,

Sequential, Ascending Single and Multiple Dose,

Safety, Tolerability, and Pharmacokinetic Study

of TAK-070 in Healthy Elderly Subjects

TAK-070 700230419 (Clinical Trials Insight),



I

243

A Randomized, Double-blind, Placebo-controlled

Study to Evaluate the Safety, Tolerability,

Pharmacokinetics, and Pharmacodynamics of

Single Oral Doses of E2609 in Subjects With Mild

Cognitive Impairment or Mild Dementia Due to

Alzheimer's Disease

E-2609 700217876 (Clinical Trials Insight),

E2609A001-101 (Eisai Inc),



I

1UH2TR000967-01 (National Institutes

of Health), 700233678 (Clinical Trials




I

Recruiting 01 Dec 2012 (actual) 01 May 2013 (planned) AstraZeneca

239

A Phase I, Randomized, Double-Blind, Placebo-

Controlled, Two-Part, Multiple Ascending Dose

Study to Assess the Safety, Tolerability,

Pharmacokinetics and Effect on Biomarkers of

AZD3293 in Plasma and Cerebrospinal Fluid in

Healthy Male and Non-Fertile Female Elderly

Volunteers and in Mild-to-Moderate Alzheimer

Disease Patients

AZD-3293 700229801 (Clinical Trials Insight),




I

238

A Phase I, Randomized, Double-Blind, Placebo-

Controlled, Single Ascending Dose Study to

Assess the Safety, Tolerability, Pharmacokinetics

and Effect on Biomarkers of AZD3293 Including

an Open-Label Food Effect Group in Healthy Male

and Non-Fertile Female Volunteers

AZD-3293 700226797 (Clinical Trials Insight),




I

Active, no longer recruiting QT interval 01 Dec 2011 (actual) 01 Jan 2013 (planned) EnVivo Pharmaceuticals

Active, no longer recruiting 01 Jun 2011 (actual) 01 Feb 2013 (planned) Biogen Idec

242

A Randomized, Double-blind, Placebo- and Active-

controlled, 3-way Crossover, Phase 1 Study to

Evaluate the Effect of EVP-6124 at Therapeutic

and Supratherapeutic Concentrations Following a

2-dose EVP-6124 Regimen on the QT Interval in

Healthy Male and Female Subjects.


EVP6124-012 (EnVivo

Pharmaceuticals), NCT01487135



I

241

A Randomized, Blinded, Placebo-Controlled

Single Ascending Dose Study of the Safety,

Tolerability, and Pharmacokinetics of BIIB037 in

Subjects With Mild to Moderate Alzheimer's

Disease.

01 Jan 2013 (actual) 01 Jun 2013 (planned) Eisai Co Ltd, Eisai Inc

Recruiting 01 Jul 2013 (actual) 01 Jun 2014 (planned)

Recruiting 01 Mar 2013 (actual) 01 Jul 2014 (planned) AstraZeneca

240

A Phase Ib Multiple Ascending Dose Study of the

Safety, Tolerability, and CNS Availability of

AZD0530 in Alzheimer's Disease.

Saracatinib

237

A Phase 1, Multicenter, Randomized, Double-

Blind, Placebo-Controlled, Adaptive, Multiple

Ascending Dose Study Of The Safety, Tolerability

And Pharmacokinetics Of AAB-003 (PF-

05236812) In Subjects With Mild To Moderate


AAB-003 700059277 (Clinical Trials Insight),


B2601001 (Pfizer), NCT01193608



236

A Phase 1 Study of E2022 Tape Formulation for

Different Application Sites and Intervals


E2022J081-003 (Eisai Inc.),



I

Recruiting baseline comparison 01 Jul 2011 (actual) 01 Oct 2014 (planned) JANSSEN Alzheimer Immunotherapy, Pfizer

235

A Multicenter, Open-label Extension, Multiple-

dose, Parallel Group Study to Investigate the

Long-term Safety and Tolerability of AAB-003

(PF-05236812) Administered Intravenously in

Subjects With Mild to Moderate Alzheimer's

Disease Previously Treated With AAB-003 or

Placebo in Protocol B2601001 [EXTENSION OF

700059277]

AAB-003 700059277 (Clinical Trials Insight),


B2601003 (Pfizer), NCT01369225



I

I Active, no longer recruiting 01 Sep 2010 (actual) 01 Oct 2013 (planned) JANSSEN Alzheimer Immunotherapy, Pfizer


Recruiting 01 Feb 2012 (actual) 01 Oct 2014 (planned) Bristol-Myers Squibb

234

A Multi-Center, Randomized, Double-Blind,

Placebo-Controlled Study to Evaluate the Safety,

Tolerability and the Effect of BMS-241027 on

Cerebrospinal Fluid Biomarkers in Subjects With

Mild Alzheimers Disease.

BMS-241027 700211166 (Clinical Trials Insight),

CN167-003 (Bristol-Myers Squibb),





I

01 Jan 2012 (actual) 01 Oct 2014 (planned) Sanofi

233

A Multi-center, Parallel-group, Double-blind,

Placebo-controlled Single and Multiple Dose

Escalation Study to Assess the Safety and

Tolerability and the Pharmacokinetic Properties of

SAR228810 Given as IV Infusion or as SC

Injection in Patients With Mild to Moderate


SAR-228810 700210693 (Clinical Trials Insight),





TDR12399 (Sanofi-Aventis), U1111-


Organisation)

I Recruiting

open Amyloid levels Amyloid-levels


multicentre Amyloid levels

prospective Drug concentration


Donepezil multicentre

Latrepirdine prospective

RG-1577 open baseline comparison Drug concentration Drug-concentration

Selegiline parallel drug regimen comparison Enzyme activity Enzyme-activity

prospective subject comparison Positron emission tomography imaging outcomes Positron-emission-tomography-imaging-outcomes

open Biomarker levels Biomarker-levels

prospective Drug concentration Drug-concentration

Pharmacokinetic parameters Pharmacokinetic-parameters

Metamfetamine randomised baseline comparison Blood pressure Pharmacokinetic-parameters

Selegiline single-blind drug combination comparison Heart rate

placebo comparison Pharmacokinetic parameters

double-blind Biomarker levels Biomarker-levels

open Drug concentration

randomised

255 Clinical Trials Insight: 700009417 VP-025 I Active, no longer recruiting double-blind placebo comparison Vasogen 700009417 (Clinical Trials Insight)

double-blind

randomised

257 Clinical Trials Insight: 700028317 CX-701 I Planning Cortex Pharmaceuticals 700028317 (Clinical Trials Insight)

258 Clinical Trials Insight: 700029703 SP-233 I Planning Samaritan Pharmaceuticals 700029703 (Clinical Trials Insight)

259 Clinical Trials Insight: 700032402 Nerve-growth-factor I Recruiting Cognitive function tests 01 Dec 2007 (actual) 01 Dec 2008 (planned) NsGene 700032402 (Clinical Trials Insight)

260 Clinical Trials Insight: 700033500 NGC-0295 I Active, no longer recruiting prospective baseline comparison 31 Dec 2009 (planned) NeuroSearch 700033500 (Clinical Trials Insight)

261 Clinical Trials Insight: 700036191 PTI-777 I Recruiting prospective baseline comparison 29 Jul 2008 (actual) ProteoTech 700036191 (Clinical Trials Insight)

262 Clinical Trials Insight: 700036262 CX-1739 I Recruiting prospective Pharmacokinetic parameters 07 Aug 2008 (actual) Cortex Pharmaceuticals 700036262 (Clinical Trials Insight)

crossover

open

randomised

264 Clinical Trials Insight: 700039184 XY-4083 I Not yet recruiting 01 Jan 2009 (planned) Xytis 700039184 (Clinical Trials Insight)

double-blind

randomised

266 Clinical Trials Insight: 700054972 NP-61 I Recruiting prospective Maximum tolerated dose Maximum-tolerated-dose 01 Jan 2008 (planned) Noscira 700054972 (Clinical Trials Insight)

267 Clinical Trials Insight: 700059035 AAD-2004 I Recruiting 01 Apr 2010 (actual) GNT Pharma 700059035 (Clinical Trials Insight)

parallel baseline comparison Area under the drug concentration time curve

prospective drug dosage comparison Drug clearance

randomised placebo comparison Drug half life

single-blind Peak drug concentration



crossover baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart


double-blind placebo comparison Cambridge Neuropsychological Test Automated

Battery

Cambridge-Neuropsychological-Test-Automated-Battery

multicentre Computerised tomography imaging outcomes Computerised-tomography-imaging-outcomes

prospective Delayed Matching to Sample Delayed-Matching-to-Sample

randomised EEG changes EEG-changes

Magnetic resonance imaging outcomes Magnetic-resonance-imaging-outcomes

Motor function Motor-function

Paired Associates Learning Paired-Associates-Learning

Pattern Recognition Memory Pattern-Recognition-Memory

Rapid visual information processing Rapid-visual-information-processing

Reaction time Reaction-time

Working memory Working-memory

Donepezil crossover baseline comparison Cognitive function tests Cognitive-function-tests

Memantine double-blind placebo comparison EEG changes

Modafinil prospective Magnetic resonance imaging outcomes

randomised

parallel baseline comparison Biomarker levels

prospective control group comparison DNA methylation

randomised Folic acid levels

single-blind Gene expression

Homocysteine levels

Donepezil crossover baseline comparison Polysomnographic measures Polysomnographic-measures

Galantamine open drug comparison Sleep measures Sleep-measures

prospective

randomised

double-blind Amyloid levels Amyloid-levels

parallel Biomarker levels Biomarker-levels

prospective Inflammatory markers Protein-levels

randomised Interleukin 8 levels Tau-levels


Oxidative stress markers

Protein levels

Tau levels

Curcumin crossover baseline comparison Alzheimer's Disease Assessment Scale cognitive

subpart

Clinical-response

Etanercept open drug combination comparison Clinical response

Flavins prospective Mini Mental State Examination

Luteolyn randomised Montreal Cognitive Assessment

Omega-3-fatty-acids

Quercetin

Resveratrol

Thioctic-acid

open Activities of Daily Living Scale Activities-of-Daily-Living-Scale

prospective Addenbrooke's Cognitive Examination Score Addenbrooke's-Cognitive-Examination-Score

Alzheimer's Disease Assessment Scale cognitive

subpart


Inflammatory markers Mini-Mental-State-Examination

Mini Mental State Examination Severe-Impairment-Battery


Vital signs

Biomarker levels Maximum-tolerated-dose

Cognitive function



double-blind

randomised

278Phase I tolerability and pharmacokinetic study of

Lu AF11167.

Lu-AF11167 I Recruiting Pharmacokinetic parameters 30 Mar 2011 (actual) Lundbeck A/S 700196735 (Clinical Trials Insight)

279 Phase I trial of ABT 354 ABT-354 I Recruiting prospective Abbott Laboratories 700208718 (Clinical Trials Insight)

280Phase I trial of an antidementia therapeutic for


Antidementias I Planning prospective Pharnext 700213275 (Clinical Trials Insight)

I Recruiting placebo comparison Pharmacokinetic parameters 03 Jan 2013 (actual)

prospective

277 Phase I single and multiple ascending dose trial

of KU 046 in healthy volunteers.

KU-046 700226929 (Clinical Trials Insight)

276

Phase I multiple ascending dose trial of

allopregnanolone in patients with mild cognitive

impairment or mild Alzheimer's disease.

Allopregnanolone 700234874 (Clinical Trials Insight)I Not yet recruiting

Kareus Therapeutics

baseline comparison 01 Oct 2012 (planned)

01 Feb 2010 (actual) 01 Jun 2015 (planned)

275

Phase I Clinical trial of the safe use of perispinal

Etanercept (Tumour Necrosis Factor-Alpha

blocker) in Australian patients with progressive

dementia

Etanercept 362840 (Australian New Zealand





Registry), U1111-1133-1715 (World

Health Organisation)

I Not yet recruiting

274

Open Label,Crossover,Pilot Study to Assess the

Efficacy & Safety of Perispinal Admin.of

Etanercept(EnbrelÂ®) in Comb.w/Nutritional

Supplements vs. Nutritional Supplements Alone

in Subj. w/Mild to Mod. Alzheimer's Disease

Receiving Std. Care.


CL025 (Life Extension Foundation),



I Recruiting

Recruiting placebo comparison 01 Jun 2010 (actual) 01 Jun 2015 (planned)

273

Effects of Simvastatin on CSF AD Biomarkers in

Cognitively Normal Subjects.

Simvastatin 00183, 37373B (University of

Washington Health Sciences),




I

Recruiting 01 Nov 2008 (actual) 01 Sep 2009 (planned) Janssen-Cilag

Not yet recruiting 01 Jan 2012 (planned) 31 Dec 2016 (planned)

272

Effects of Galantamine and Donepezil on the

Amount and the Quality on the Sleep in Patients

Suffering From Alzheimer Disease.


CHU0038 (Clermont-Ferrand University

Hospital), NCT00750529


I

01 Nov 2011 (actual) 01 Jul 2013 (planned)

271

Effects of folic acid intervention on the patients of

Alzheimer's disease by DNA methylation

Folic-acid 700233785 (Clinical Trials Insight),

ChiCTR-TRC13003246 (Chinese Clinical

Trial Register)

I

Recruiting 01 Dec 2011 (actual) 01 Dec 2013 (planned)

270

Effects of 15-day Donepezil and Memantine on

Cognitive Functions After a 24 Hours Sleep

Deprivation Challenge in Healthy Volunteers: a

Double-blind, Placebo-controlled, Randomised,

Cross-over Study, With Modafinil as Positive

Control.





National Institutes of Health), WP1P001

I Recruiting

01 Apr 2013 (actual) 01 Feb 2014 (planned) ICURE

269

Effect of a 15-day Donepezil Treatment on

Biomarkers of AD in Healthy Volunteers.






I

268

Dose escalation with donepezil patch in health

males.

Donepezil IPI001 (Icure Pharmaceutical Inc.),




I Active, no longer recruiting

Pharmacokinetic parameters Mithridion265 Clinical Trials Insight: 700051217 MCD-386 700051217 (Clinical Trials Insight)I Planning placebo comparison

Pharmacokinetic parameters 21 Oct 2008 (actual) Debiopharm263

Clinical Trials Insight: 700038235 Mimopezil 700038235 (Clinical Trials Insight)I Recruiting drug formulation comparison

30 Jun 2007 (planned) Lexicon PharmaceuticalsActive, no longer recruiting placebo comparison Pharmacokinetic parameters 31 Jan 2007 (actual)256 Clinical Trials Insight: 700020636 LX-6171 700020636 (Clinical Trials Insight)I

placebo comparison 01 Oct 2005 (actual) 01 Aug 2009 (planned)

01 Sep 2001 (actual) 01 Oct 2002 (actual)

254

Biomarkers of Nonsteroidal Anti-Inflammatories. Ibuprofen 700010621 (Clinical Trials Insight),





11 Feb 2010 (actual) 01 Dec 2011 (planned) QR Pharma

253

Assessment of Potential Interactions Between

Intravenous Methamphetamine and Oral

Selegiline



National Institutes of Health), NIDA-

CTO0004-1 (National Institute on Drug


Genentech, Roche

252

An Open-Label, Two-Stage Study to Evaluate the

Pharmacokinetics and Pharmacodynamics of

POSIPHEN in Plasma and CSF After a 10-Day

Treatment Period in Subjects With Amnestic Mild

Cognitive Impairment.

R-phenserine 700053584 (Clinical Trials Insight),


National Institutes of Health), QR12001

(QR Pharma)

I Recruiting baseline comparison

251

An Open-Label, Parallel Group Study to Assess

the Inhibition of Brain MAO-B by RO4602522

After Repeated Dosing in Patients With

Alzheimer's Disease and in Healthy Control

Subjects


BP28253 (Hoffmann-La Roche),



I Recruiting 01 Sep 2012 (actual) 01 Jan 2013 (planned)

01 Mar 2008 (actual) 01 Dec 2008 (planned) Medivation

Pfizer

250

An Open-Label Extension Study of Combination

Therapy With Dimebon and Donepezil in Patients



DIM13 (Medivation), NCT00704782




Active, no longer recruiting drug dosage comparison 01 Aug 2008 (actual) 01 May 2009 (planned)

249

An Open Label, Single Dose Escalation Study Of

PF-04360365 In Subjects With Mild To Moderate


Ponezumab 700036851 (Clinical Trials Insight),

A9951008 (Pfizer), NCT00733642



I

I Not yet recruiting baseline comparison 01 Jun 2013 (planned)

248

A study evaluating the effects of Apolipoprotein E

driven therapeutics for Alzheimer's disease

Bexarotene 364100 (Australia New Zealand Clinical

Trial Registry Request Number),


ACTRN12613000465752 (Australian

New Zealand Clinical Trials Registry),

U1111-1141-4103 (World Health

281Phase I trial of DSP 8658 for the treatment of


DSP-8658 I Recruiting prospective 01 Feb 2012 (actual) Dainippon Sumitomo Pharma 700213714 (Clinical Trials Insight)

282 Phase I trial of EVP 0962 in volunteers. EVP-0962 I Recruiting double-blind Pharmacokinetic parameters 01 Jun 2011 (actual) EnVivo Pharmaceuticals 700201709 (Clinical Trials Insight)

283

Phase I trial of FGLS (trial 1). FGLS I Planning prospective 01 Jun 2012 (planned) ENKAM Pharmaceuticals A/S 700210927 (Clinical Trials Insight),



284




285




286Phase I trial of IRX 4204 in patients with


IRX-4204 I Planning prospective baseline comparison Io Therapeutics 700223135 (Clinical Trials Insight)

double-blind

prospective

randomised

double-blind Area under the drug concentration time curve Area-under-the-drug-concentration-time-curve

prospective Drug clearance Drug-clearance

randomised Drug half life Drug-half-life

Drug volume of distribution Drug-volume-of-distribution

Peak drug concentration Peak-drug-concentration

Time to peak drug concentration Time-to-peak-drug-concentration

double-blind baseline comparison Neurological parameters Peak-drug-concentration

parallel drug dosage comparison Peak drug concentration

prospective placebo comparison Repeatable Battery for Assessment of

Neuropsychological Statusrandomised

290

Planned phase I trial of a sustained-release

formulation of sGC 1061 for treatment of

Alzheimer's disease and age-related cognitive

impairment.

SGC-1061 I Planning prospective baseline comparison Pharmacokinetic parameters Alzheimers Drug Discovery Foundation, sGC

Pharma



crossover baseline comparison

double-blind drug dosage comparison


randomised

292Vanutide cridificar in patients with mild to


Vanutide-cridificar I Recruiting prospective Pharmacokinetic parameters 01 Oct 2005 (actual) Elan Pharmaceuticals 700012470 (Clinical Trials Insight)



prospective Cognitive function tests

randomised Tau levels

multicentre Cognitive function tests

prospective Laboratory parameters


double-blind

randomised

open Clinical response

parallel Patient compliance

randomised

double-blind

multicentre

randomised

298 Clinical Trials Insight: 700046023 KRONOS-IV Planning 01 Feb 2010 (planned) Endogenous Stem Cells Activators Inc. 700046023 (Clinical Trials Insight)

multicentre baseline comparison Cognitive function tests Structured-Clinical-Interview-for-DSM-Disorders

prospective control group comparison Cost

randomised Delis Kaplan executive function system

single-blind Dementia Quality of Life

EuroQoL

General Self Efficacy Scale

Hospital Anxiety and Depression Rating Scale

Stress measures

Structured Clinical Interview for DSM Disorders

Test of Everyday Attention

WHO Quality of Life BREF

multicentre Cost per patient Treatment-outcome

open Treatment outcome

prospective

Donepezil baseline comparison

Galantamine drug comparison

prospective Functional clinical response 01 Nov 2005 (actual) 01 Jul 2007 (planned)

301

The effect of cholinesterase inhibitors on

neuromuscular function in patients with

Alzheimer's disease



Register: National Health Service),


Register: National Health Service)


baseline comparison 30 Apr 2014 (planned)

01 Oct 2012 (actual) 31 Jan 2017 (planned)

300

Self-management in dementia: a pilot trial of the

development, efficacy and cost-effectiveness of a

self-management group intervention



(Clinical Trials Insight)

Recruiting

299

Goal-oriented cognitive Rehabilitation in Early-

stage Alzheimer's disease: multi-centre single-

blind randomised controlled Trial (GREAT)

Antidementias 12WA0185 (Multicentre Research

Ethics Committee (MREC)), 12WA0185

(North Wales Research Ethics

Committee), 13632 (United Kingdom

Clinical Research Network), 21027481



Recruiting

01 Jun 2009 (planned)

297Clinical study of an investigational drug in

patients with mild to moderate Alzheimer's

disease

Antidementias 700013823 (Clinical Trials Insight)Active, no longer recruiting placebo comparison

Recruiting 01 Apr 2008 (actual)296

Clinical efficacy of Donepezil on self care ability

in patients with both diabetes and Alzheimer's

disease




295

A double-blind, randomized, placebo-controlled

study of the efficacy, safety and tolerability of 8-

week treatment of Rozerem [ramelteon] 8mg

(QHS) in sleep-disturbed, community-dwelling,

mild to moderately severe Alzheimer's disease

subjects

Ramelteon 05112904 (Rush University Medical


Insight)

Recruiting placebo comparison

Active, no longer recruiting 16 Nov 2006 (actual) 31 Oct 2009 (planned)

01 Apr 2012 (actual) 01 Dec 2013 (planned)

294

A [11C] raclopride investigation of the influence

of donepezil upon striatal dopamine function in

patients with alzheimer's disease



Register: National Health Service)

Echo Pharmaceuticals

293

Safety And Target Engagement Of Clu1 By

Valproic Acid In Subjects With Intact Cognition:

Proof Of Concept For The Development Of A

Prevention Trial For Alzheimer's Disease.

Valproic-acid 12-0068F6A (University of Kentucky),




0 Recruiting

I Recruiting Drug concentration 01 Aug 2012 (actual) 01 Dec 2012 (planned)

291

Safety and Tolerability of Oral NamisolÂ®, a

Tablet Containing Delta-9-Tetrahydrocannabinol,

in Elderly Subjects: A Randomized Controlled

Trial

Dronabinol 700226965 (Clinical Trials Insight),


Clinical Trials Database), GER001-02-

03 (Radboud University Medical Centre

Nijmegen), NCT01740960


289

Phase I, Single-center, Inpatient, Randomized,

Double-blind, Placebo-controlled, Dose Escalating

Study to Evaluate the Safety, Tolerability and

Pharmacokinetic Profiles of Single Oral Doses of

AVL-3288 (Anvylic-3288) Healthy Subjects.

AVL-3288 12-1186 (University of Colorado,

Denver), 700232813 (Clinical Trials




I

288

Phase I, Randomized, Double-Blind, Placebo

Controlled, Dose Escalation,Single Dose, Safety,

Tolerance, and Pharmacokinetic Study of CXB909

in Healthy Male Volunteers.

CXB-909 700212084 (Clinical Trials Insight),

CXB909100 (CeNeRx BioPharma),



I Not yet recruiting drug dosage comparison

287

Phase I, Double-Blind, Placebo-Controlled,

Ascending, Single-Dose, Safety, Tolerability and

Pharmacokinetic Study of Bisnorcymserine

(BNC), a Highly Selective Inhibitor of

Butyrylcholinesterase, in Healthy Adult

Volunteers

Bisnorcymserine 13AG-N034 (National Institute on

Aging), 700220643 (Clinical Trials

Insight), 999913034 (National

Institutes of Health Clinical Center),



Recruiting 01 Jun 2013 (actual) 01 May 2015 (planned) Anvyl Pharmaceuticals

01 Dec 2013 (planned) QR Pharma

01 Dec 2012 (planned) 01 Dec 2014 (planned) CeNeRx BioPharma

I Recruiting baseline comparison Pharmacokinetic parameters 01 Nov 2012 (actual)

Documents

Alzheimer's Disease Ongoing Trials 2013...Alzheimer's-Disease-Cooperative-Study-Activities-of Daily-Living-Inventory prospective drug vs drug + nondrug comparison Assessment scale