1
$284 Wednesday, November 9, 2005 Poster Abstracts There were numerically more responders among galantamine-treated patients in the VaD group for ADAS-cog/I 1, NPI, and CIBIC-Plus than placebo (INS). Discussion: Among completers, there was statistically significant clinical benefits with galantanfine for coguition, global function, and behavior for patients with AD+CVD. The lack of statistical significance in the VaD galantamine group may be due to increased responders in the VaD placebo group possibly recovering from stroke. 0723 Long Term Survival of Patients with Alzhehner's Disease with and without Cerebrovascular Disease Treated with Galantauline Feldman, H ~, Everitt, B, Van Baelen, B2, Kavanagh, S~, Brashear, H 4. 1Division of Neurology, University of British Coh#nbia Hospital, Vancouver Costal Health Research Institute, Vancouver, BC, Canada; 2SGS-Medisearch; 3Yanssen Pharmaceutica NIL Beerse, Belgium; 4Johnson arid Johnson Pharmaceutical Research arid Development, Titusville, New Jersey, USA Background: Alzheimer's disease (AD) and cerebrovascular disease (CVD) are associated with an increased mortality risk. Tire sympto- matic benefits of galantanfine, an acetylcholinesterase inlfibitor and nicotinic receptor modulator, have been demonstrated in AD, and AD+CVD. The effects o f galantamine on mortality in these conditions can be further evaluated. Objective: To investigate the effects of galantamine on mortality in AD, AD+CVD and vascular dementia (VaD). Methods: 1. To determine mortality rates from a retrospective recontact study (RRS) of subjects from 4 trials, up to 7 years later. 2. Meta-analysis of mortality data from 7 short-teml trials of galantamJne in AD, AD+C.VD, and VaD. In the RRS, Cox proportional hazards models were used to examine the association between galantamine and mortality controlling for potential mortality risk factors. Trial adjusted Mantel-Haenszel odds ratios were calculated for tile shorter-term meta-analysis. Results: The RRS included 722 subjects with mean follow-up of 1288 days. There were 417 subjects with AD, 163 with AD+CVD and 142 with probable VaD. The median survival of patients with <6 months galantanfine exposure was 60.8 months while it was 74.8 months with > 6 months exposure (Log rank test 5.0458, p -- 0.0247). There was no siguificant effect of galantanfine on mortality in tire 5 placebo-controlled trials of 6 months in AD (OR) 0.98, 95% CI 0.48- 1.98), or in the two 6 month trials of AD+CVD or VaD (OR) 0.46, 95% CI 0.20-1.03). Conclusion: These data indicate no increased mortality associated with galantanfine treatment of AD, AD+CVD and VaD. 0724 Caregiver Bmden in AD: Results of a Pilot Proslaedive Sludy (ECO Study) in Spain Frank-Garcia A a, Berinejo F 2, Leon I "3, Lopez-Arrieta JM 4, Del Llano 34, Coduras A 4, Lara-Lara M 1, Rejas js. 1Departrnent of Neurology, University Hospital La Paz, Madrid, Spain; 2Department of Neurology, University Hospital 12 de Oetubre, Madrid, Spain; 3Medical Department, Pfizer Spain, Aleobendas, Spain; 4Fundaeitn Gaspar CasM, Madrid, Spain; 5Outcomes Research, Medical Unit, Pfizer Spain, Aleobendas, Spain Background: To measure caregiver burden at different Alzheimer's Disease (AD) stages in a pilot study in Spain. Method: Pilot phase of a prospective, open label and multicenter study including mild, moderate and severe AD according with the NINCDS-ADRDA criteria. Cognitive function (MMSE), global function (CDR), neuropsychJatic symptoms (NPI), quality of life (SF-36), caregiver burden (Zarit) and daily living activities (DAD) were evaluated. Results: 40 AD patients (68% women), aged over 50 years (mean age - 74.8 d- 7.0 years) with a stable caregiver were selected from two tertiary hospitals. AD stage: 50% mild, 40% moderate and 10% severe. Tile majority of patients were receiving specific treatment for AD (85% received Anticholinesterase hflfibitors (AChIs) distributed as follows: donepezil 42%, fivastig~ifine 38%, galantamine 17%, tacrine 4%). 64% of caregivers were spouses. Only 10% of AD patients were institutionalized and 83% lived with the caregiver. In 89% of cases, informal caregiver support was the only or main help available and only 11% received economic support from public funds. Average scores in Zarit and NPI scales were 24.2 and 14.7, respectively. 42.1% of caregivers dedicated more than 8 hours a day assisting the AD patient. Only 22.5% of patients attended a day care centre. There was no correlation between age and severity of the disease. Conclusions: Very few AD patients were institutiot~alized. The majority of caregivers were spouses. AD represented a considerable burden for tire caregiver. Formal and public supports were scarce. 0725 Sensitivity and Spedfidty of tile Free and Cued Selective Reminder Test (FCSRT). Data of the Spanish PRIDEM-70 Project SarLz, A ~, Ortiz, X ~, Talltn, A a, Navarro, T 2, Diez-Tejedor, E l, Lara-Lara, M ~, Frank-Garcia, A ~. 1Department of Neurology. University Hospital La Paz, Madrid, Spain; :Department of Nuclear Medicine. University Hospital La Paz, Madrid, Spain Background: This is a substudy of a project (PRIDEM-70) which aim consists in identifying risk profiles for dementia in volunteers over 70 years old living in Madrid, Spain. Amnesic Mild Cognitive Impairment (MCI) has a fast evolution to Alzheimer's Disease (AD), so we analyze episodic memory with tire Free and Cued Selective Renfinder Test (FCSRT) looking for its Sensitivity (S) and Specificity (Sp) for detecting MCI and dementia. Method: Written informed consent was obtained from each participant in the PRIDEM-70 Project. We studied in three diagnostic groups: healthy volunteers (HV), MCI patients and patients with Mild Alzheimer's Disease (MAD) the total FCSRT score. Subjects were also examined with tile 7MS as a reference test. Statistical analysis: Descriptive, ANOVA, ROC's curve and Pearson's correlation. Results: Seventy nine subjects (HV -- 41; MCI -- 17; MAD -- 21) participated in this study. The mean age was 76,84 -c 4,34 years and there were 40 women. Tile total FCSRT score resulted siguifi- cantly different anrong the groups (F -- 58,51; p < 0,001) as follows: HV: 42,20 ± 5,4; MCI: 24,06 4_ 9,8; MAD: 15,00 5_13,4. Tile cut-off to mmxirnize the greatest S and Sp in order to detect dementia was 19 (IS: 92%; Sp: 71%), whereas the best cut-off to distinguish between MCI and MAD was 39 (IS: 78%; Sp: 97%). The 7MS as reference test showed a good correlation with the FSCRT (r -- 0,80; p < 0,001). Conclusion: 1-n our PRIDEM-70 sanrple the FSCRT appears to be a good instrument to detect MCI. Besides, FSCRT is also getting normalized in a Spanish population and our results could be useful for this proposal. 0726 Test-Retest and Interobserver Reliability of EUROTEST Frank-Garcia, A 1, Carlrero-Pardo, C 2 Guardado-SantervA.s, p2, Rubi-Callej6n, j2, Gbmez-Camello, A 3, Gofii-bifizcoz, M 4, IndatkoeO~ea-Juanbeltz, B 5, Lacruz-Bescoz, F 6, Sfinchez-Cantalejo, t~ 7, Lara-Lara M ~. 1Department of Neurology- University Hospital La Paz, Madrid, Spain; 2Hospital Torreedrdenas, Abnerla, Spain; 3Hospital San Cecilia, Granada, Spain; 4Hospital Divino Vall~s, Burgos, Spain; 5Hospital de Donosita, San Sebastidn, Spain; 6Hospital de Navarra, Pamplona Spain; 7Escuela Andaluza de Salud P~blica, Granada, Spain

0724 Caregiver burden in AD: Results of a pilot prospective study (ECO study) in Spain

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Page 1: 0724 Caregiver burden in AD: Results of a pilot prospective study (ECO study) in Spain

$284 Wednesday, November 9, 2005 Poster Abstracts

There were numerically more responders among galantamine-treated patients in the VaD group for ADAS-cog/I 1, NPI, and CIBIC-Plus than placebo (INS). Discussion: Among completers, there was statistically significant clinical benefits with galantanfine for coguition, global function, and behavior for patients with AD+CVD. The lack of statistical significance in the VaD galantamine group may be due to increased responders in the VaD placebo group possibly recovering from stroke.

0723 Long Term Survival of Patients with Alzhehner's Disease with and without Cerebrovascular Disease Treated with Galantauline

Feldman, H ~, Everitt, B, Van Baelen, B 2, Kavanagh, S ~, Brashear, H 4. 1Division of Neurology, University of British Coh#nbia Hospital, Vancouver Costal Health Research Institute, Vancouver, BC, Canada; 2SGS-Medisearch; 3Yanssen Pharmaceutica NIL Beerse, Belgium; 4Johnson arid Johnson Pharmaceutical Research arid Development, Titusville, New Jersey, USA

Background: Alzheimer's disease (AD) and cerebrovascular disease (CVD) are associated with an increased mortality risk. Tire sympto- matic benefits of galantanfine, an acetylcholinesterase inlfibitor and nicotinic receptor modulator, have been demonstrated in AD, and AD+CVD. The effects o f galantamine on mortality in these conditions can be further evaluated. Objective: To investigate the effects of galantamine on mortality in AD, AD+CVD and vascular dementia (VaD). Methods: 1. To determine mortality rates from a retrospective recontact study (RRS) of subjects from 4 trials, up to 7 years later. 2. Meta-analysis of mortality data from 7 short-teml trials of galantamJne in AD, AD+C.VD, and VaD. In the RRS, Cox proportional hazards models were used to examine the association between galantamine and mortality controlling for potential mortality risk factors. Trial adjusted Mantel-Haenszel odds ratios were calculated for tile shorter-term meta-analysis. Results: The RRS included 722 subjects with mean follow-up of 1288 days. There were 417 subjects with AD, 163 with AD+C VD and 142 with probable VaD. The median survival of patients with <6 months galantanfine exposure was 60.8 months while it was 74.8 months with > 6 months exposure (Log rank test 5.0458, p -- 0.0247). There was no siguificant effect of galantanfine on mortality in tire 5 placebo-controlled trials of 6 months in AD (OR) 0.98, 95% CI 0.48- 1.98), or in the two 6 month trials of AD+CVD or VaD (OR) 0.46, 95% CI 0.20-1.03). Conclusion: These data indicate no increased mortality associated with galantanfine treatment of AD, A D + C V D and VaD.

0724 Caregiver Bmden in AD: Results of a Pilot Proslaedive Sludy (ECO Study) in Spain

Frank-Garcia A a, Berinejo F 2, Leon I "3, Lopez-Arrieta JM 4, Del Llano 34, Coduras A 4, Lara-Lara M 1, Rejas js. 1Departrnen t of Neurology, University Hospital La Paz, Madrid, Spain; 2Department of Neurology, University Hospital 12 de Oetubre, Madrid, Spain; 3Medical Department, Pfizer Spain, Aleobendas, Spain; 4Fundaeitn Gaspar CasM, Madrid, Spain; 5Outcomes Research, Medical Unit, Pfizer Spain, Aleobendas, Spain

Background: To measure caregiver burden at different Alzheimer's Disease (AD) stages in a pilot study in Spain. Method: Pilot phase of a prospective, open label and multicenter study including mild, moderate and severe AD according with the NINCDS-ADRDA criteria. Cognitive function (MMSE), global function (CDR), neuropsychJatic symptoms (NPI), quality of life (SF-36), caregiver burden (Zarit) and daily living activities (DAD) were evaluated.

Results: 40 AD patients (68% women), aged over 50 years (mean age - 74.8 d- 7.0 years) with a stable caregiver were selected from two tertiary hospitals. AD stage: 50% mild, 40% moderate and 10% severe. Tile majority of patients were receiving specific treatment for AD (85% received Anticholinesterase hflfibitors (AChIs) distributed as follows: donepezil 42%, fivastig~ifine 38%, galantamine 17%, tacrine 4%). 64% of caregivers were spouses. Only 10% of AD patients were institutionalized and 83% lived with the caregiver. In 89% of cases, informal caregiver support was the only or main help available and only 11% received economic support from public funds. Average scores in Zarit and NPI scales were 24.2 and 14.7, respectively. 42.1% of caregivers dedicated more than 8 hours a day assisting the AD patient. Only 22.5% of patients attended a day care centre. There was no correlation between age and severity of the disease. Conclusions: Very few AD patients were institutiot~alized. The majority of caregivers were spouses. AD represented a considerable burden for tire caregiver. Formal and public supports were scarce.

0725 Sensitivity and Spedfidty of tile Free and Cued Selective Reminder Test (FCSRT). Data of the Spanish PRIDEM-70 Project

SarLz, A ~, Ortiz, X ~, Talltn, A a, Navarro, T 2, Diez-Tejedor, E l, Lara-Lara, M ~, Frank-Garcia, A ~. 1Department of Neurology. University Hospital La Paz, Madrid, Spain; :Department of Nuclear Medicine. University Hospital La Paz, Madrid, Spain

Background: This is a substudy of a project (PRIDEM-70) which aim consists in identifying risk profiles for dementia in volunteers over 70 years old living in Madrid, Spain. Amnesic Mild Cognitive Impairment (MCI) has a fast evolution to Alzheimer's Disease (AD), so we analyze episodic memory with tire Free and Cued Selective Renfinder Test (FCSRT) looking for its Sensitivity (S) and Specificity (Sp) for detecting MCI and dementia. Method: Written informed consent was obtained from each participant in the PRIDEM-70 Project. We studied in three diagnostic groups: healthy volunteers (HV), MCI patients and patients with Mild Alzheimer's Disease (MAD) the total FCSRT score. Subjects were also examined with tile 7MS as a reference test. Statistical analysis: Descriptive, ANOVA, ROC's curve and Pearson's correlation. Results: Seventy nine subjects (HV -- 41; MCI -- 17; MAD -- 21) participated in this study. The mean age was 76,84 -c 4,34 years and there were 40 women. Tile total FCSRT score resulted siguifi- cantly different anrong the groups (F -- 58,51; p < 0,001) as follows: HV: 42,20 ± 5,4; MCI: 24,06 4_ 9,8; MAD: 15,00 5_13,4. Tile cut-off to mmxirnize the greatest S and Sp in order to detect dementia was 19 (IS: 92%; Sp: 71%), whereas the best cut-off to distinguish between MCI and MAD was 39 (IS: 78%; Sp: 97%). The 7MS as reference test showed a good correlation with the FSCRT (r -- 0,80; p < 0,001). Conclusion: 1-n our PRIDEM-70 sanrple the FSCRT appears to be a good instrument to detect MCI. Besides, FSCRT is also getting normalized in a Spanish population and our results could be useful for this proposal.

0726 Test-Retest and Interobserver Reliability of E U R O T E S T

Frank-Garcia, A 1, Carlrero-Pardo, C 2 Guardado-SantervA.s, p2, Rubi-Callej6n, j2, Gbmez-Camello, A 3, Gofii-bifizcoz, M 4, IndatkoeO~ea-Juanbeltz, B 5, Lacruz-Bescoz, F 6, Sfinchez-Cantalejo, t~ 7, Lara-Lara M ~. 1Department of Neurology- University Hospital La Paz, Madrid, Spain; 2Hospital Torreedrdenas, Abnerla, Spain; 3Hospital San Cecilia, Granada, Spain; 4Hospital Divino Vall~s, Burgos, Spain; 5Hospital de Donosita, San Sebastidn, Spain; 6Hospital de Navarra, Pamplona Spain; 7Escuela Andaluza de Salud P~blica, Granada, Spain