The Brain Health Registry: Lessons learned and next steps for remote, online AD and aging clinical research

Abstract

BackgroundRemote, internet‐based methods for recruitment, screening, and longitudinally assessing older adults have the potential to greatly facilitate Alzheimer’s disease and related research, including clinical trials and observational studies.MethodsThe Brain Health Registry (BHR) is an online website and registry that includes a comprehensive battery of self‐ and study partner‐report questionnaires and online neuropsychological tests. Participants are asked to return at 6‐month intervals for longitudinal follow‐up. Recently, new online infrastructure for managing remote biomarker (saliva, blood) collection and for linking in‐clinic and online data were added. Multiple current initiatives aim to increase recruitment and engagement of underrepresented populations using digital, community engaged research strategies to improve generalizability of results. These include the recent launch of a Spanish‐language website, and projects focused on increasing enrollment and task completion of Black/African American and Hispanic/Latinx individuals.ResultsBHR includes >95,000 participants, >9000 of whom have enrolled study partners, 40% return for longitudinal follow up, 64% are age 55+, 80% are female, 80% identify as Non‐Latinx White, and 10% identify as Hispanic/Latinx. Participants have an average of 16.2 years of education. BHR has made >86,000 referrals to other studies, resulting in >5000 BHR participants enrolled in 25 different aging and AD observational studies and treatment trials. Over 2400 participants are co‐enrolled in BHR and collaborator studies, with online data linked to in‐clinic data. 573 participants have undergone APOE genotyping using remote saliva collection, and 629 have had blood collected using local phlebotomy for AD plasma biomarker analysis. Accumulating evidence supports the feasibility and validity of the approach, including associations with in‐clinic assessments, the ability to accurately detect MCI and enrichment for amyloid positivity.ConclusionsMajor advantages of the BHR approach are scalability and accessibility. Challenges include compliance, retention, and cohort diversity. Lessons learned from BHR, and components of the existing infrastructure, can be used to inform future remote clinical trial design. One such future effort is ADNI4. To facilitate enrollment of new participants, ADNI4 will establish an online recruitment and screening portal, with a remote phlebotomy component, to efficiently identify those from underrepresented populations, and those likely to have preclinical and prodromal AD.

Brain Health Registry Study Partner Portal: Novel infrastructure for digital, dyadic data collection

“…26,27 These findings also are consistent with a previous analysis of the BHR cohort, 28 BHR participants enrolled in 30 different studies. 13 Dyadic BHR data can be used in the future to identify participants to be referred to studies seeking older adults with MCI, including observational studies and treatment trials.…”

“…Collection of dyadic subjective decline data in the Study Partner Portal represents a scalable, efficient strategy for screening older adults for cognitive impairment relevant to AD, especially in light of past work demonstrating a strong relationship between BHR study partner–report ECog scores and clinically confirmed MCI diagnosis 14 . One of the main ways that BHR facilitates AD and related research is through referral of BHR participants to other studies, with more than 25,997 BHR participants enrolled in 30 different studies 13 . Dyadic BHR data can be used in the future to identify participants to be referred to studies seeking older adults with MCI, including observational studies and treatment trials.…”

“…The BHR is a public online registry. Adults (age 18+) can register, sign a digital informed consent, and complete online longitudinal tasks at 6‐month intervals, including questionnaires and neuropsychological assessments 10,13 . The BHR study is approved by the University of California, San Francisco Internal Review Board.…”

“…Adults (age 18+) can register, sign a digital informed consent, and complete online longitudinal tasks at 6-month intervals, including questionnaires and neuropsychological assessments. 10,13 The BHR study is approved by the University of include a short health screener, and the following scales adapted for online use 9 : Everyday Cognition Scale (ECog), 15 Functional Activities Questionnaire (FAQ), 16,17 Cognitive Function Instrument (CFI), 18,19 and Mild Behavioral Impairment Checklist (MBI-C).…”

“…7,8 Although most dyadic data are collected in in-clinic studies, dyadic data collection has been adapted recently to remote, unsupervised settings. 5,[9][10][11][12] The Brain Health Registry (BHR) Study Partner Portal is a novel and scalable platform to support remote collection of study partner data 10,13 within the University of California, San Francisco Brain Health Registry. BHR is an online cognitive aging and ADRD-related research registry and cohort (N > 92,000 participants).…”