Clarksburg

Researchers are evaluating the effects of atorvastatin 40 mg compared to a placebo in older adults aged 75 years and above who live in the community without cardiovascular disease, dementia, or significant disability. This Phase 4 study aims to determine if statins can reduce death, dementia, persistent disability, mild cognitive impairment, and cardiovascular events. The study involves about 20,000 participants across roughly 100 US sites, including both VA and non-VA locations, with inclusion of English or Spanish speakers. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study drug will be mailed directly to participants every 90 days starting immediately after randomization and continuing as long as the participant remains on the study drug. Enrollment and follow-up may include in-person visits or telehealth options. Baseline assessments include physical function tests, cognitive and physical function phone screens annually, and blood samples for lipid panels and biorepository specimens. Lipid testing is repeated at 3 months in a subset of participants. During the study, researchers will collect data through phone assessments, electronic health records, Medicare records, and the National Death Index to monitor cognitive and physical function, cardiovascular events, and other outcomes. Participants will be followed for up to 5 years, with an estimated median follow-up of 3.8 years. Safety and adherence will be supported by centralized recruitment, retention efforts, and direct mailing of study medication, with ongoing monitoring for dementia diagnosis, disability, and cardiovascular events.