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Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.

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

Author information

1
Department of Neurology, Washington University in St Louis, St Louis, MO, USA. Electronic address: batemanr@wustl.edu.
2
Department of Radiology, Washington University in St Louis, St Louis, MO, USA.
3
Berry Consultants, Austin, TX, USA.
4
Department of Neurology, Washington University in St Louis, St Louis, MO, USA.
5
Indiana Alzheimer Disease Center, Indiana University, Indianapolis, IN, USA.
6
Memory and Aging Program, Butler Hospital, Brown Medical School, Providence, RI, USA.
7
Alzheimer's Disease Research Center, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
8
Department of Biostatistics, Washington University in St Louis, St Louis, MO, USA.

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.

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

PMID:
27583651
PMCID:
PMC5218895
DOI:
10.1016/j.jalz.2016.07.005
[Indexed for MEDLINE]
Free PMC Article

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