Cognitive Health in Underrepresented Populations—Early Learnings From INTUITION: A Brain Health Study (P14-6.009)

Abstract

<h3>Objective:</h3> The aims of INTUITION (NCT 05058950)—an observational, 2-year, virtual study—are to develop real-world, high-accuracy classifiers that distinguish mild cognitive impairment from healthy aging and to construct a trackable cognitive health score. Brain health in underrepresented populations is less studied. Consequently, various recruitment and engagement strategies have been used in INTUITION to enroll a representative population. <h3>Background:</h3> Recruitment and retention of demographically diverse populations is an evolving challenge in clinical research. It remains to be seen how digital decentralized studies might transform the engagement landscape for research that aims to enroll cohorts reflective of large, heterogeneous populations, such as those in the United States. Given that socioeconomic factors are associated with vulnerability to cognitive decline and are potential determinants of health, research characterizing risks to brain health should use strategies to enroll representative populations. <h3>Design/Methods:</h3> The study recruitment strategy includes multiple channels, such as email/direct mail campaigns, paid search, and social media, word-of-mouth, and event-based outreach in collaboration with patient advocacy groups. This study collects digital, multimodal, longitudinal data via iPhone and Apple Watch, coupled with the results of validated cognitive tests and behavioral surveys. We will compare recruitment strategies and evaluate adherence to digital tool use, with a focus on data from underrepresented populations by age group and cognitive status. <h3>Results:</h3> INTUITION has enrolled &gt;95% of its total target population since the study launch. The study population comprises individuals from generally underrepresented populations with varying degrees of risk for cognitive decline. The most successful recruitment strategies were word-of-mouth and email/direct mail campaigns. Up-to-date study population characteristics and an assessment of the recruitment strategies will be presented. <h3>Conclusions:</h3> INTUITION demonstrates that virtual studies offer the potential to enroll populations that accurately reflect the diversity of the larger society. <b>Disclosure:</b> Mr. Hobbs has received personal compensation for serving as an employee of Biogen. Mr. Hobbs has stock in Biogen. Dr. Au has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Au has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Au has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Au has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NovoNordisk. Dr. Au has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GSK. Dr. Au has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Dr. Au has received publishing royalties from a publication relating to health care. Dr. Au has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant with Davos Alzheimer’s Collaborative. Dr. Au has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant with High Lantern. Dr. Becker has received personal compensation for serving as an employee of Biogen. Dr. Butler has received personal compensation for serving as an employee of Biogen. Dr. Butler has stock in Biogen. Dr. Lenyoun has received personal compensation for serving as an employee of Apple. Dr. Lenyoun has stock in Apple. Mr. Kenny has received personal compensation for serving as an employee of Biogen. Mr. Kenny has stock in Biogen. Dr. Brown has received personal compensation for serving as an employee of Biogen. Dr. Brown has stock in Biogen. Dr. Saha-Chaudhuri has received personal compensation for serving as an employee of Biogen. Dr. Saha-Chaudhuri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Saha-Chaudhuri has stock in Biogen. Matt Bianchi has nothing to disclose. Dr. Williams has received personal compensation for serving as an employee of Biogen. Dr. Williams has received stock or an ownership interest from Biogen. Audrey Gabelle has nothing to disclose. Dr. Belachew has received personal compensation for serving as an employee of Biogen Inc. Dr. Belachew has received stock or an ownership interest from Biogen Inc.