[P4–021]: AN ANALYTICAL FRAMEWORK FOR PROJECTING THE COGNITIVE EFFECT OF COMBINATION THERAPY WITH INTEPIRDINE (RVT‐101) AND DONEPEZIL VERSUS PLACEBO AFTER 24 WEEKS IN MILD‐MODERATE ALZHEIMER's DISEASE

Background: Recruitment and retention of early Alzheimer’s patients in clinical trials provide both challenges and opportunities for improvement (Watson, 2012). To expedite recruitment of 24 participants at a single clinical site for NCT02221622 we sought to move past traditional recruitment approaches. We discuss innovative methods to recruit, retain, and budget for an early phase trial in a university setting. Methods: Recruitment materials included paper and web-based flyers, social media, health fairs, and radio advertisements (3 local radio stations). All recruitment materials were approved by IRB. Qualified staff with current protected health information compliance certificates conducted phone pre-screens and entered caller information into a secure REDCap database. The Clinical Study Coordinator called potential volunteers for follow-up phone interviews and scheduled first screening visit. Many participants (55%) opted to use taxi transportation (Uber) that allowed real-time smartphone tracking for both the caregivers and clinicians, improving appointment efficiency. Other than reimbursements for transportation and parking costs, no other compensation benefits were afforded. The trial was conducted at USC and funded by NIH-NIA and ADDF. Results: Of the recruitment materials used, radio advertisements were most effective. Radio Station: KUSC (11.8%), KNX (86.3%), KOST (0.0%), Other (2.0%). Self-referral: Yes (45.7%), No (54.3%). Age range: 5691, mean 71.47 +/-10.19. Previous diagnosis of dementia: Yes (48.8%), No (51.2%). Study Partner available: Yes (92.3%), No (7.7%). Previous MRI: Yes (42.1%), No (42.1%), Maybe (15.8%). Pre-screen results: Pass (31.6%), Fail (17.1%), Declined to participate (17.1%), Called for information only (34.2%). Of those that passed pre-screen inclusion/exclusion criteria, 47% of those screened at clinic were enrolled with acceptable MRI results andMMSE>20. To date, of those enrolled, there has been only one dropout. Conclusions: We developed an effective recruitment framework to enroll 24 volunteers with early Alzheimer’s disease into a double-blind placebo controlled phase-Ib study to test the safety of once-per-week intravenous Allopregnanolone, a candidate regenerative therapeutic. Recruitment was most effective through brief radio advertisements followed by prescreening interviews and medical record review to recruit willing volunteers. Our recruitment strategy utilized local radio announcements and convenient ride-share transportation and serves as an innovative model for efficient clinical trial recruitment. P4-021 AN ANALYTICAL FRAMEWORK FOR PROJECTING THE COGNITIVE EFFECT OF COMBINATION THERAPY WITH INTEPIRDINE (RVT-101) AND DONEPEZIL VERSUS PLACEBO AFTER 24 WEEKS IN MILD-MODERATE ALZHEIMER’S DISEASE Steven Rich, James B. Leverenz, Shankar Ramaswamy, Harald Hampel, Rochester Regional Health, Rochester, NY, USA; Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH, USA; Axovant Sciences, Inc., New York, NY, USA; AXA Research Fund, Sorbonne Universit es, Universit e Pierre et Marie Curie (UPMC) Paris, Inserm, CNRS, Institut du Cerveau et de la Moelle (ICM), Institut de la M emoire et de la Maladie d’Alzheimer (IM2A), Paris, France; Sorbonne Universities, Pierre et Marie Curie University, Paris, France; Hopital de la Pitie-Salpetriere, Paris, France; INSERM, Institut du Cerveau et de la Moelle Epiniere (ICM), Paris, France; Universit e Pierre et Marie Curie (UPMC), Paris, France; Institut de la M emoire et de la Maladie d’Alzheimer (IM2A), ICM, Salpetriere Hospital, AP-HP, University Paris, Paris, France. Contact e-mail: Steven.Rich@rochesterregional.org