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Advisory Council February 2017 Meeting Presentation: Randomized Controlled Trials

Friday, February 3, 2017

Printer Friendly Version in PDF Format (4 PDF pages)

 

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 https://clinicaltrials.gov/

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
  • PCORI
  • BAI's Alzheimer's Prevention Registry
  • Global Alzheimer's Platform
  • Alzheimer's Association TrialMatch

February 3, 2017 -- Advisory Council Meeting #23

The meeting was held on Friday, February 3, 2017, in Washington, DC. The theme of this Advisory Council meeting was clinical trials for Alzheimer's disease and related dementias and recruitment challenges. Additional afternoon presentations included updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council's 2017 Recommendations, due in April 2017. Material available from this meeting is listed below and is also available at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services-meetings#Feb2017.

Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.

 

General Information

 

Handouts

 

Presentation Slides

 

Videos

  • Welcome thru Perspectives -- [Video]

  • Rachel, Jessica, George Presentations -- [Video]

  • Keith Presentation and Panel Discussion -- [Video]

  • Public Comments -- [Video]

  • Care Summit and Milestones -- [Video]

  • Federal Workgroups and Adjourn -- [Video]