title: Report of the task force on designing clinical trials in early (predementia) AD.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  A consensus has been achieved in support of the testing of candidate treatments in the early (predementia) AD population.
authors.affiliation: Department of Neurosciences, UCSD, 9500 Gilman Drive M/C 0949, La Jolla, CA 92093, USA paisen@ucsd.org
authors.forename: P S
authors.initials: PS
authors.lastname: Aisen
authors.forename: S
authors.initials: S
authors.lastname: Andrieu
authors.forename: C
authors.initials: C
authors.lastname: Sampaio
authors.forename: M
authors.initials: M
authors.lastname: Carrillo
authors.forename: Z S
authors.initials: ZS
authors.lastname: Khachaturian
authors.forename: B
authors.initials: B
authors.lastname: Dubois
authors.forename: H H
authors.initials: HH
authors.lastname: Feldman
authors.forename: R C
authors.initials: RC
authors.lastname: Petersen
authors.forename: E
authors.initials: E
authors.lastname: Siemers
authors.forename: R S
authors.initials: RS
authors.lastname: Doody
authors.forename: S B
authors.initials: SB
authors.lastname: Hendrix
authors.forename: M
authors.initials: M
authors.lastname: Grundman
authors.forename: L S
authors.initials: LS
authors.lastname: Schneider
authors.forename: R J
authors.initials: RJ
authors.lastname: Schindler
authors.forename: E
authors.initials: E
authors.lastname: Salmon
authors.forename: W Z
authors.initials: WZ
authors.lastname: Potter
authors.forename: R G
authors.initials: RG
authors.lastname: Thomas
authors.forename: D
authors.initials: D
authors.lastname: Salmon
authors.forename: M
authors.initials: M
authors.lastname: Donohue
authors.forename: M M
authors.initials: MM
authors.lastname: Bednar
authors.forename: J
authors.initials: J
authors.lastname: Touchon
authors.forename: B
authors.initials: B
authors.lastname: Vellas
mesh_terms: D026683:Advisory Committees; D000544:Alzheimer Disease / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D058227:Amyloidogenic Proteins / Q000097:blood; D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic / Q000379:methods*; D003071:Cognition / Q000187:drug effects; D032921:Consensus; D018450:Disease Progression; D000077265:Donepezil; D004345:Drug Industry; D042241:Early Diagnosis; D005060:Europe; D006801:Humans; D007189:Indans / Q000627:therapeutic use; D007391:International Cooperation; D018697:Nootropic Agents / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D010880:Piperidines / Q000627:therapeutic use; D049268:Positron-Emission Tomography; D012107:Research Design; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014810:Vitamin E / Q000627:therapeutic use
chemical_list: D058227:Amyloidogenic Proteins; D015415:Biomarkers; D007189:Indans; D018697:Nootropic Agents; D010880:Piperidines; D014810:Vitamin E; D000077265:Donepezil