Article (Scientific journals)
Report of the task force on designing clinical trials in early (predementia) AD
Aisen, P.; Andrieu, S.; Sampaio, C. et al.
2011In Neurology, 76, p. 280-286
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Keywords :
trials; alzheimer; design
Abstract :
[en] BACKGROUND: A large number of promising candidate disease-modifying treatments for Alzheimer disease (AD) continue to advance into phase II and phase III testing. However, most completed trials have failed to demonstrate efficacy, and there is growing concern that methodologic difficulties may contribute to these clinical trial failures. The optimal time to intervene with such treatments is probably in the years prior to the onset of dementia, before the neuropathology has progressed to the advanced stage corresponding to clinical dementia. METHOD: An international task force of individuals from academia, industry, nonprofit foundations, and regulatory agencies was convened to discuss optimal trial design in early (predementia) AD. RESULTS: General consensus was reached on key principles involving the scope of the AD diagnosis, the selection of subjects for trials, outcome measures, and analytical methods. CONCLUSION: A consensus has been achieved in support of the testing of candidate treatments in the early (predementia) AD population.
Research center :
GIGA CRC (Cyclotron Research Center) In vivo Imaging-Aging & Memory - ULiège
Disciplines :
Neurology
Author, co-author :
Aisen, P.
Andrieu, S.
Sampaio, C.
Carrillo, M.
Khachaturian, Z.
Dubois, Bruno
Feldman, H.
Petersen, R.
Siemers, H.
Doody, R.
Hendrix, S.
Grundman, M.
Schneider, L.
Schindler, R.
Salmon, Eric  ;  Université de Liège - ULiège > Département des sciences cliniques > Neuroimagerie des troubles de la mémoire et révalid. cogn.
Potter, W.
Thomas, R.
Salmon, D.
Donohue, M.
Bednar, M.
Touchon, J.
Vellas, B.
More authors (12 more) Less
Language :
English
Title :
Report of the task force on designing clinical trials in early (predementia) AD
Publication date :
2011
Journal title :
Neurology
ISSN :
0028-3878
eISSN :
1526-632X
Publisher :
Lippincott Williams & Wilkins, Hagerstown, United States - Maryland
Volume :
76
Pages :
280-286
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 03 January 2012

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