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

Abstract

AbstractBackgroundThe 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.MethodApheleia‐001 prescreens potential participants using paper and digital cognitive tests, demographic and medical information, and blood biomarkers. Apheleia‐001 procedures are completed in <2 hours and they minimize both site and participant burden. Participants eligible through Apheleia‐001 are referred to an early phase therapeutic AD trial.Apheleia‐001 will enroll ∼1600 participants across 28 clinical trial sites in both North America and Europe with an expected 24‐month enrollment period.ResultApheleia‐001 is currently open for enrollment and data is being collected. As of 18Jan2023, Apheleia‐001 has completed 300+ prescreens and has identified over 60 trial eligible participants. Of the 300+ prescreened, 35% have identified as an underrepresented minority (URM). It is projected that the Apheleia pre‐screener will ultimately reduce the screen failure rate of a specific sponsor clinical trial by up to 50%.ConclusionApheleia‐001 is projected to accelerate clinical trial enrollment and reduce the cost of an early phase therapeutic AD clinical trial. With this approach, initial screen fails will be done more efficiently (e.g., reduced speed and cost) compared to traditional clinical trial approaches. In addition, Apheleia‐001 optimizes sites for randomizations, therefore improving site resource utilization and finances. If scaled, Apheleia‐001 could significantly impact recruitment timelines across multiple studies, reducing the cost and burden of clinical trial recruitment and execution for sponsors, sites, and participants.