Recruitment strategies and tactics for INTERCEPT‐AD: A phase I trial of Aβ oligomer‐targeting ACU193 in early Alzheimer's disease.

Background: Clinical trials are essential for testing safety and efficacy of potential treatments for Alzheimer's disease (AD), but recruitment is often difficult due to a variety of factors. Recruitment tactics in AD clinical trials may include media advertising, physician referrals, patient registries, and referral campaigns. Newer strategies such as social media and community outreach have also been successful in increasing recruitment. However, not all recruitment tactics are successful for every study site and a multi‐faceted approach tailored to each site may be more successful. Method: INTERCEPT‐AD is a phase 1 randomized, double‐blind study of ACU193 in mild cognitive impairment or mild dementia due to AD. Seventeen study sites in the U.S. screened potential participants identified through multiple recruitment tactics which were grouped post hoc into seven categories: site database, external referral, physician referral, site campaign, and three sponsor‐initiated campaigns. Recruitment efforts were tailored to each site's patient population, community, and staff availability. Result: INTERCEPT‐AD screened 260 participants and 70 were eligible for study participation. Recruitment was completed in January 2023. The sponsor worked directly with individual sites to develop a tailored recruitment plan that considered each site's target population, historically successful recruitment tactics, and current ability to screen patients from outside sources. Comparisons of the seven types of recruitment sources showed site databases were used most frequently (12/17 sites, 71%) and accounted for the most screenings and eligible participants (107 [41%] and 32 [46%], respectively). Additional data from all recruitment sources and success rates will be presented. Conclusion: Study sites found success using a combination of tactics specifically tailored to their enrollment goals. Sites with robust internal patient databases had higher rates of screening and enrollment. A combination of site‐led and sponsor‐driven recruitment initiatives likely maximized enrollment rates. These findings suggest a strategy using diverse recruitment tactics customized to a study site's capabilities and patient population may be more successful than a one‐size‐fits‐all approach. [ABSTRACT FROM AUTHOR]