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Abstract
Older individuals face barriers to participating in center-based clinical trials, including logistical and health issues that lessen adherence. The Alzheimer’s Association U.S. POINTER study is a multicenter trial (N=2,500) of individuals at increased risk for cognitive decline (60–79 years, sedentary lifestyle, poor diet, suboptimum cardiovascular and metabolic health status, parental history of significant memory impairment). It contrasts two lifestyle interventions, delivered at local YMCAs and Association chapters and differing in level of support, to encourage active lifestyles, healthy diets, social and intellectual engagement, and risk factor management. Recruitment through clinical trial networks begins with data-mining medical records to cull ineligible individuals and target those living proximal to intervention and data collection sites. Intervention protocols accommodate health events that compromise adherence. We report recruitment yields and describe data-mining algorithms tailored to enhance yields, protocols to enhance intervention adherence and heighten rigor, and approaches to trial design that promote dissemination and reproducibility.
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1 Wake Forest School of Medicine, Winston Salem, North Carolina, United States
2 Department of Internal Medicine, Wake Forest School of Medicine, Winstion-Salem, NC USA
3 Medical and Scientific Relations, Alzheimer’s Association, Chicago, IL
4 Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden
5 Medical and Scientific Relations, Alzhiemer’s Association, Chicago, IL, USA
6 Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA
7 Kaiser Permanente Division of Research, Oakland, CA, USA
8 Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA