WP1 Progress report

Vienna, 13 March 2011

AchievementsGeneral

- 4 Staff members (1 Image Analyst, 1 part-time Radiologist, 2 Research Assistants) in place

- Obtained approval from Medicines and Healthcare products Regulatory Agency

- Local Ethical Approval obtained provisionally, pending clarifications

AchievementsStructural Imaging

1 Site survey ✔2 Site selection ✔3 Radiological and structural protocols (ADNI-GO) for 3T

scanners finalised and Manual sent to sites ✔4 Image Management System (TrialTracker) and electronic

data transfer tool (TrialWire) ✔

1 Sites to upload protocol and return protocol form in progress2 Sites to scan phantom and send details to IXICO in progress3 Sites to scan 1 healthy volunteer and send details to IXICO

not startedQualification and start scanning

AchievementsStructural Imaging

3T SITESurvey

SentSurvey

ReceivedProtocol

SentProtocol Received

ACR Phantom at Site

ACR Phantom Scan Requested

ACR Phantom Scan Received

London Y Y Y Y Y Y YPrague Y Y Y Y Y Y YLeuven Y Y Y Y Y Y YUtrecht Y Y Y Y Y Y NMelbourne Y Y Y Y Y Y NCopenhagen Y Y Y Y Y Y NTel Aviv Y Y Y Y Y Y NMadrid Y Y Y Y N N NNaples Y Y Y N N N NBucharest Y Y Y N N N N

Innsbruck considering to join WP1

AchievementsMagnetic Resonance Spectroscopy1 London, Copenhagen, Utrecht have met and agreed

protocol2 Spectra (anterior cingulate and thalamus) from

Copenhagen and Utrecht can be read and give reasonable values

3 The data can provide metabolite ratios4 Currently exploring whether we can do correction for

CSF in the MRS voxel which is a superior approach to the ratio method

Milestones 1 Completion of preparation work for MRI sites

2 Start scanning

Deliverables1 Qualification of sites, test of electronic data transfer tool

2 Estimate of numbers (200 in total: if 10 sites, 20 patients per site)

Possible concerns

Combination of MRS data:

- Existing power calculation did not take into account the greater variability of multicentre design

- Increase number of subjects with MRS at each site (~30-40 each: existing plan is for 20 subjects scanned twice in London and Copenhagen, so it would be slightly more than double)

- If datasets cannot be combined, we could explore whether findings are reproduced across sites

Planned progress- Obtain final approval from local ethics- Qualify sites- Start recruitment and scanning- All sites to continue to scan phantom regularly plus 2

healthy volunteers (from the site) yearly, preferably every 6 months and before and after upgrades