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Home > Report of the task force on designing clinical trials in early (predementia) AD.

TitleReport of the task force on designing clinical trials in early (predementia) AD.
Publication TypeJournal Article
Year of Publication2011
AuthorsAisen, PS, Andrieu, S, Sampaio, C, Carrillo, M, Khachaturian, ZS, Dubois, B, Feldman, HH, Petersen, RC, Siemers, E, Doody, RS, Hendrix, SB, Grundman, M, Schneider, LS, Schindler, RJ, Salmon, E, Potter, WZ, Thomas, RG, Salmon, D, Donohue, M, Bednar, MM, Touchon, J, Vellas, B
JournalNeurology
Volume76
Issue3
Pagination280-6
Date Published2011 Jan 18
ISSN1526-632X
KeywordsAdvisory Committees, Alzheimer Disease, Amyloidogenic Proteins, Biomarkers, Clinical Trials as Topic, Cognition, Consensus, Disease Progression, Drug Industry, Early Diagnosis, Europe, Humans, Indans, International Cooperation, Nootropic Agents, Outcome Assessment (Health Care), Patient Selection, Piperidines, Positron-Emission Tomography, Research Design, Treatment Outcome, United States, United States Food and Drug Administration, Vitamin E
Abstract

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.

DOI10.1212/WNL.0b013e318207b1b9
Alternate JournalNeurology
PubMed ID21178097
PubMed Central IDPMC3034393
Top50 Topics: 
Diagnosis, Imaging, Methods, Clinical Trials
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