F4‐03‐01: Collaboration for Alzheimer's Prevention (CAP): Advancing the Evaluation of Preclinical Alzheimer's Disease Treatments

The field of Alzheimer disease (AD) prevention trials is at a critical period whereby a number of large and very informative trials are underway covering a spectrum of preclinical AD: autosomal dominant AD (ADAD), apolipoprotein4 (APOE4) carriers, and sporadic AD. Given the nascence of the field of prevention trials in neurodegenerative diseases, collaboration on fundamental aspects of these projects is critical to ensure maximal progress. The Collaboration for Alzheimer's Prevention (CAP) was founded by representatives from the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study, Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), Alzheimer's Prevention Initiative (API), the Food and Drug Administration (FDA), the National Institute on Aging (NIA), the Alzheimer's Association and F-Prime Biomedical Research Initiative (FBRI). Additionally, researchers from the TOMORROW trial later joined CAP, but during this talk, we will focus on those projects representing public-private partnerships. CAP was initiated in 2011 to bring together AD prevention trial researchers to learn from and support each other's work. For instance, we have focused to date on efforts including sharing data between studies; charting new territory in terms of outcome measures in the preclinical space; harmonizing data gathering and trial outcomes to allow for comparability across studies; and holding open, informal dialogue with regulators. We will discuss how each of these important collaborative efforts in CAP are instrumental to ongoing trials. We specifically highlight novel design considerations for these trials and discuss major challenges that provide the greatest opportunity for the evolution of these trials. Prevention trials in AD have benefited greatly from years of trials in symptomatic AD. However, by nature, prevention trials require a distinct approach to enable the goals of identifying effective therapies and also contributing to advancements in our understanding of disease progression to aid in our development of both diagnostic and theragnostic biomarkers. Cooperatives such as CAP offer an opportunity to more effectively work towards both of these goals while, themselves, continuing to evolve.