Advisory Council February 2017 Meeting Presentation: Randomized Controlled Trials



Friday, February 3, 2017

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Randomized Controlled Trials for Alzheimer's Disease

National Alzheimer's Project Act: Goal

To effectively treat Alzheimer's dissease (delay onset, slow progression) by 2025

RCT's for Alzheimer's Disease

  • Challenges 12 Phase 3 failures in the past 10 years
  • Last drug approved by the FDA for AD: 2003
  • 332 active trials for Alzheimer's disease on

Drug Development in Alzheimer's Disease

Diagram on drug development.

RCT Recruitment

  • Trials large, long, expensive, inefficient
  • FDA trying to help the process
  • Often the major impediment to the execution of a RCT in AD is participant recruitment

US Plan to Address Alzheimer's Disease

  • Action 1.B.3: Increase enrollment in clinical trials and other clinical research
    • through community, national, and international outreach Increased enrollment in clinical trials is crucial for the development of better treatments and ultimately a cure for AD. Participating in clinical trials and other research enables volunteers to access the latest experimental approaches available and provides them with care by clinical research staff.

NIH Alzheimer' Disease Research Summits

  • Recommendations include language like:
    • Expand large-scale registries and natural history cohorts of healthy individuals from early midlife to late-life as well as individuals with subjective and/or objective cognitive impairment and use the data to inform clinical trial design. These cohorts should be population-based and should oversample underrepresented ethnic minorities and groups with lower education.

Clinical Trials in ADRD: Recruitment Challenges

  • Overview
  • FDA Perspective
  • NIA Perspective
  • BAI's Alzheimer's Prevention Registry
  • Global Alzheimer's Platform
  • Alzheimer's Association TrialMatch

Return to

National Alzheimer's Project Act Home Page

Advisory Council on Alzheimer's Research, Care, and Services Page

Advisory Council on Alzheimer's Research, Care, and Services Meetings Page