Development of Clinical Trial Simulation Tools for Alzheimer’s Disease through the Critical Path for Alzheimer’s Disease (CPAD) Consortium

Critical Path Institute (C‐Path) coordinates the Critical Path for Alzheimer’s Disease (CPAD) Consortium. To accelerate DRUG DEVELOPMENT for Alzheimer’s Disease (AD), CPAD developed two regulatory‐endorsed clinical trial simulation (CTS) that sponsors can use to help optimize clinical trial design in 1) the pre‐dementia stages of AD, using CDR‐SB as the primary endpoint, and 2) mild‐to‐moderate AD, using ADAS‐cog as the primary cognitive endpoint. Recently, CPAD members have shared data from several contemporary Phase III clinical trials, offering an opportunity to enrich and expand these model‐based tools with additional fluid and imaging biomarker information, data from predementia subjects and treatment arms.