ORBi: Aisen P. - Report of the task force on designing clinical trials in early (predementia) AD

Reference : Report of the task force on designing clinical trials in early (predementia) AD


	Document type :	Scientific journals : Article
	Discipline(s) :	Human health sciences : Neurology
	To cite this reference:	http://hdl.handle.net/2268/106994

Title :	Report of the task force on designing clinical trials in early (predementia) AD
Language :	English
Author, co-author :	Aisen, P. [ > > ]
	Andrieu, S. [ > > ]
	Sampaio, C. [ > > ]
	Carrillo, M. [ > > ]
	Khachaturian, Z. [ > > ]
	Dubois, B. [ > > ]
	Feldman, H. [ > > ]
	Petersen, R. [ > > ]
	Siemers, H. [ > > ]
	Doody, R. [ > > ]
	Hendrix, S. [ > > ]
	Grundman, M. [ > > ]
	Schneider, L. [ > > ]
	Schindler, R. [ > > ]
	Salmon, Eric [Université de Liège - ULg > 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. [ > > ]
Publication date :	2011
Journal title :	Neurology
Publisher :	Lippincott Williams & Wilkins
Volume :	76
Pages :	280-286
Audience :	International
ISSN :	0028-3878
e-ISSN :	1526-632X
City :	Hagerstown
Country :	MD
Keywords :	[en] 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 units :	Centre de Recherches du Cyclotron - CRC
Permalink :	http://hdl.handle.net/2268/106994

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