Apheleia‐001: A novel prescreening study designed to enrich and accelerate Alzheimer’s disease clinical trials by efficiently identifying trial‐eligible participants determined to have a high probability of study inclusion, including amyloid positivity

Background The clinical development ecosystem cannot support the current demand for participants needed in Alzheimer’s disease clinical trials which is further disrupted by: 1) high screen fail rates (≥80‐90%); 2) lengthy screening visits constraining site resources; 3) unnecessary participant burden. The field demands a unique approach to optimize site resource utilization, participant/caregiver time, and overall development costs. Apheleia‐001 will identify patients with a high probability of meeting study‐specific eligibility criteria for a therapeutic Alzheimer’s disease clinical trial. Method Apheleia‐001 prescreens potential participants using paper and digital cognitive tests, demographic and medical information, and blood biomarkers. Apheleia‐001 procedures are completed in