Internet-based recruitment, screening, and longitudinal assessment of subjects for neuroscience clinical trials using the Brain Health Registry
Background: The high cost of identifying, recruiting, screening, and assessing eligible participants for neuroscience clinical trials is a major obstacle to developing effective treatments. The BrainHealthRegistry.org (BHR), launched in 2014, offers a unique approach to facilitate clinical trials for brain diseases. The BHR captures online detailed, longitudinal health and lifestyle information and measures of cognitive function from a large cohort of registrants. The overall goal is to accelerate development of new treatments for brain diseases.
Methods: After registration and consent, BHR participants complete a series of questionnaires, including measures of demographics, overall health, medication use, memory, family history of brain disease, mood, sleep, diet, and exercise. Participants also complete online neuropsychological tests (NPTs), including the Cogstate Brief Battery and the Lumos Brain Performance Test. All tasks are completed online with no supervision. Subjects are invited to return to BHR every 6 months to complete additional online tasks and repeat NPTs. We analyzed the demographic and cognitive profiles of the general BHR cohort, as well as those who completed 6-month follow up NPTs, to analyze eligibility for hypothetical Alzheimer’s disease (AD) clinical trials.
Results: The BHR has over 11,000 subjects, with 54% residing within the San Francisco Bay Area. The average age of registrants is 57±14.6 years, and a total of 6704 registrants are over age 55. Sixty-nine percent are female, 13% belong to racial or ethnic minorities, and 84% have a college degree. For subjects over age 55 years, 3% report having dementia, and 44% report a first-degree relative with AD. Subjective memory problems were reported by 44% of older adults. Twenty-four percent of subjects over 55 score at least 1 standard deviation below the age-adjusted mean on NPTs, and 87% of those subjects also endorse a memory problem. Forty-eight percent of subjects returned to the BHR website for a 6-month follow up aimed at longitudinal data collection, and 64% of returners completed all follow-up tasks. The average age of returners is 61±12.1 years, and 73% are female. Fifty-six percent of older returners endorse a memory problem, and 33% have family history of AD.
Conclusions: The BHR contains a significant number of subjects who would be eligible for AD clinical trials based on demographics and cognitive function. A large percentage of subjects eligible for AD clinical trials completed follow-up NPTs. Compared to the general population, the demographic of BHR registrants underrepresents racial minorities and those with low levels of educational attainment, groups that are also underrepresented in many clinical trials. Although women are traditionally underrepresented in clinical trials, they are overrepresented in the BHR cohort, comprising more than 60% of all registrants. The results demonstrate the feasibility of using an Internet-based registry for subject recruitment and screening for AD clinical trials, and for using longitudinal cognitive data to select subjects likely to be at an early disease state. This model of subject recruitment, screening, and assessment can be applied broadly to neuroscience clinical trials to accelerate the development of new treatments.