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

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• 作者：Randall J. Bateman^a ; ^{batemanr@wustl.edu} ; Tammie L. Benzinger^b ; Scott Berry^c ; David B. Clifford^a ; Cynthia Duggan^a ; Anne M. Fagan^a ; Kathleen Fanning^a ; Martin R. Farlow^d ; Jason Hassenstab^a ; Eric M. McDade^a ; Susan Mills^a ; Katrina Paumier^a ; Melanie Quintana^c ; Stephen P. Salloway^e ; Anna Santacruz^a ; Lon S. Schneider^f ; Guoqiao Wang^g ; Chengjie Xiong^g ; the DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network
• 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
• 刊名：Alzheimer's & Dementia
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：13
• 期：1
• 页码：8-19
• 全文大小：1320 K
• 卷排序：13

文摘

We describe innovative trial design features of interest for Alzheimer's disease (AD) adaptive or prevention trials. Dominantly Inherited Alzheimer Network (DIAN) observational study data were used to model autosomal dominant AD (ADAD) cognitive decline. The DIAN Trials Unit (DIAN-TU) cognitive composite is sensitive to early cognitive changes in ADAD. The disease progression model significantly improves power over traditional analytical methods. The DIAN-TU Next Generation prevention trial will test therapeutics to prevent or slow cognitive decline in the ADAD population.