Recruitment, Screening, and Follow-Up
Overview
The HADRC targets a diverse population of over 5 million residents across Harris, Fort Bend, and Galveston Counties. To ensure the cohort reflects these regional demographics, the HADRC commits to a recruitment strategy where at least 50% of participants belong to understudied populations. Recruitment is a multi-channel effort, leveraging dementia centers, primary care settings, and Outreach, Recruitment, and Engagement Core activities, with all longitudinal follow-ups centralized at the Houston Methodist Neal Neurological Center.
Focus Areas
- Early-Stage Progression- Focusing on participants with Mild Cognitive Impairment to better track disease-modifying therapy responses and sex-based biological differences.
- Proactive Enrollment- Utilizing "Proxy-chart" identification to enroll care partners of individuals aged 60+ via EHR access before symptoms emerge.
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Study Participant Screening Procedures: The Clinical Core manages the rigorous transition from community screening to formal study enrollment:
- Inclusion/Exclusion: Focuses on participants aged 60–85 who are either Cognitively Unimpaired or have Mild Cognitive Impairment.
- Key Exclusion: Fluency in English or Spanish is required; recent amyloid-targeting therapy is prohibited.
- Quality Control: The Clinical Core has the authority to implement selective enrollment freezes if a site deviates from sex or demographic diversity targets.
- Preclinical Readiness- Building a "trial-ready" registry of asymptomatic individuals with positive AD biomarkers, supported by educational resources from the Outreach Recruitment and Engagement Core.
- Data-Driven Oversight- Implementing a centralized tracking tool via the Data Management and Statistics Core to monitor enrollment targets in real-time and adjust strategies at individual sites as needed.
Impact
By prioritizing a representative cohort and focusing on the MCI stage, the HADRC will provide high-quality, diverse data essential for evaluating the effectiveness of emerging disease-modifying therapies. The integration of preclinical registries and early partner identification ensures a steady pipeline for clinical trials, ultimately accelerating the development of interventions that are applicable to a broad, real-world population.