EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials

P. Aisen, J. Touchon, R. Amariglio, S. Andrieu, R. Bateman, J. Breitner, M. Donohue, B. Dunn, R. Doody, N. Fox, S. Gauthier, M. Grundman, S. Hendrix, C. Ho, M. Isaac, R. Raman, P. Rosenberg, R. Schindler, L. Schneider, R. SperlingP. Tariot, K. Welsh-Bohmer, M. Weiner, B. Vellas

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

At a meeting of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force in December 2016, an international group of investigators from industry, academia, and regulatory agencies reviewed lessons learned from ongoing and planned prevention trials, which will help guide future clinical trials of AD treatments, particularly in the pre-clinical space. The Task Force discussed challenges that need to be addressed across all aspects of clinical trials, calling for innovation in recruitment and retention, infrastructure development, and the selection of outcome measures. While cognitive change provides a marker of disease progression across the disease continuum, there remains a need to identify the optimal assessment tools that provide clinically meaningful endpoints. Patient- and informant-reported assessments of cognition and function may be useful but present additional challenges. Imaging and other biomarkers are also essential to maximize the efficiency of and the information learned from clinical trials.

Original languageEnglish
Pages (from-to)116-124
Number of pages9
JournalThe journal of prevention of Alzheimer's disease
Volume4
Issue number2
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

Keywords

  • Alzheimer’s disease
  • clinical trials
  • cognitive composites
  • cognitive outcome measures
  • informant-reported outcome measures
  • mild behavioral impairment
  • molecular imaging
  • patient-reported outcome measures
  • secondary prevention trials

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    Aisen, P., Touchon, J., Amariglio, R., Andrieu, S., Bateman, R., Breitner, J., Donohue, M., Dunn, B., Doody, R., Fox, N., Gauthier, S., Grundman, M., Hendrix, S., Ho, C., Isaac, M., Raman, R., Rosenberg, P., Schindler, R., Schneider, L., ... Vellas, B. (2017). EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials. The journal of prevention of Alzheimer's disease, 4(2), 116-124. https://doi.org/10.14283/jpad.2017.13