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The DIAN‐TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model
Author(s) -
Bateman Randall J.,
Benzinger Tammie L.,
Berry Scott,
Clifford David B.,
Duggan Cynthia,
Fagan Anne M.,
Fanning Kathleen,
Farlow Martin R.,
Hassenstab Jason,
McDade Eric M.,
Mills Susan,
Paumier Katrina,
Quintana Melanie,
Salloway Stephen P.,
Santacruz Anna,
Schneider Lon S.,
Wang Guoqiao,
Xiong Chengjie
Publication year - 2017
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2016.07.005
Subject(s) - clinical trial , medicine , disease , adaptive design
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.