The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model

DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network

Research output: Contribution to journalArticle

87 Scopus citations

Abstract

Introduction The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) trial is an adaptive platform trial testing multiple drugs to slow or prevent the progression of Alzheimer's disease in autosomal dominant Alzheimer's disease (ADAD) families. With completion of enrollment of the first two drug arms, the DIAN-TU now plans to add new drugs to the platform, designated as the Next Generation (NexGen) prevention trial. Methods In collaboration with ADAD families, philanthropic organizations, academic leaders, the DIAN-TU Pharma Consortium, the National Institutes of Health, and regulatory colleagues, the DIAN-TU developed innovative clinical study designs for the DIAN-TU NexGen prevention trial. Results Our expanded trial toolbox consists of a disease progression model for ADAD, primary end point DIAN-TU cognitive performance composite, biomarker development, self-administered cognitive assessments, adaptive dose adjustments, and blinded data collection through the last participant completion. Conclusion These steps represent elements to improve efficacy of the adaptive platform trial and a continued effort to optimize prevention and treatment trials in ADAD.

Original languageEnglish (US)
Pages (from-to)8-19
Number of pages12
JournalAlzheimer's and Dementia
Volume13
Issue number1
DOIs
StatePublished - Jan 1 2017

Keywords

  • Adaptive clinical trial
  • Alzheimer's disease
  • Alzheimer's prevention trial
  • Amyloid
  • Autosomal dominant Alzheimer's disease
  • Biomarkers
  • Cognitive composite
  • DIAN-TU
  • Disease progression model
  • Dose adjustment
  • Tau

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Cellular and Molecular Neuroscience

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