Constructing a Local Potential Participant Registry to Improve Alzheimer’s Disease Clinical Research Recruitment

Article type: Research Article

Authors: Grill, Joshua D.^{a; b; c; d; *} | Hoang, Dan^a | Gillen, Daniel L.^{a; e} | Cox, Chelsea G.^a | Gombosev, Adrijana^b | Klein, Kirsten^a | O’Leary, Steve^a | Witbracht, Megan^a | Pierce, Aimee^{a; f}

Affiliations: [a] Institute for Memory Impairments and Neurological Disorders, University of California Irvine, CA, USA | [b] Institute for Clinical and Translational Science, University of California Irvine, CA, USA | [c] Department of Psychiatry and Human Behavior, University of California Irvine, CA, USA | [d] Department of Neurobiology and Behavior, University of California Irvine, CA, USA | [e] Department of Statistics, University of California Irvine, CA, USA | [f] Department of Neurology, University of California Irvine, CA, USA

Correspondence: [*] Correspondence to: Joshua D. Grill, 3204 Biological Sciences III, University of California Irvine, Irvine, CA 92697 4545, USA. E-mail: jgrill@uci.edu.

Abstract: Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer’s disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries.

Keywords: Clinical trial, preclinical Alzheimer’s disease, recruitment, registries

DOI: 10.3233/JAD-180069

Journal: Journal of Alzheimer's Disease, vol. 63, no. 3, pp. 1055-1063, 2018