期刊
ALZHEIMERS & DEMENTIA
卷 13, 期 1, 页码 8-19出版社
WILEY
DOI: 10.1016/j.jalz.2016.07.005
关键词
Alzheimer's disease; Alzheimer's prevention trial; Adaptive clinical trial; Biomarkers; Disease progression model; Cognitive composite; Dose adjustment; DIAN-TU; Amyloid; Tau; Autosomal dominant Alzheimer's disease
资金
- Anonymous Foundation
- Alzheimer's Association
- GHR Foundation
- DIAN-TU Pharma Consortium
- Eli Lilly
- Roche
- NIH [U01AG042791, U01 AG042791-S1, R1AG046179, R01NS065667, UF1AG032438]
- Avid Radiopharmaceuticals
- Cogstate
- Bracket
- Dominantly Inherited Alzheimer Network (DIAN) - National Institute on Aging [U19AG032438]
- German Center for Neurodegenerative Diseases (DZNE)
- BrightFocus Foundation
- Amgen
- AstraZeneca
- Biogen
- Eisai
- Forum
- Janssen AIP
- Pfizer
- Sanofi-Aventis
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. (C) 2016 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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