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

P S Aisen1, S Andrieu, C Sampaio

  • 1Department of Neurosciences, UCSD, 9500 Gilman Drive M/C 0949, La Jolla, CA 92093, USA paisen@ucsd.org

Neurology
|December 24, 2010
PubMed
Abstract

Insights

Testing Alzheimer disease (AD) treatments early, before dementia onset, is recommended. Consensus supports clinical trials in the predementia AD population to improve treatment efficacy.

Area of Science:

  • Neurology
  • Clinical Trials
  • Neurodegenerative Diseases

Background:

  • Numerous disease-modifying treatments for Alzheimer disease (AD) are in development.
  • Many clinical trials have failed to show efficacy, possibly due to methodological issues.
  • Intervention is likely most effective in the predementia stage, before significant neuropathology.

Purpose of the Study:

  • To discuss and establish optimal clinical trial design for early (predementia) Alzheimer disease.
  • To address challenges in current Alzheimer disease research and development.

Main Methods:

  • An international task force comprising experts from academia, industry, foundations, and regulatory agencies was formed.
  • The task force convened to deliberate on critical aspects of early-stage Alzheimer disease clinical trials.

Main Results:

  • Consensus was reached on core principles for AD trial design.
  • Key areas of agreement include AD diagnosis scope, subject selection criteria, outcome measures, and analytical approaches.

Conclusions:

  • There is a consensus supporting the testing of candidate treatments in the predementia Alzheimer disease population.
  • This approach aims to improve the success rate of disease-modifying therapies for Alzheimer disease.

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