Montrose

Researchers are evaluating the impact of atorvastatin, a cholesterol-lowering drug, on preventing death, dementia, and persistent disability in adults aged 75 years and older who do not have cardiovascular disease or dementia. This large, randomized, placebo-controlled phase 4 study aims to understand the benefits of statins in older adults living in the community. The trial also examines secondary outcomes such as mild cognitive impairment and cardiovascular events. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study plans to enroll about 20,000 participants from around 100 sites across the U.S., including both VA and non-VA locations. The treatment will continue for up to 5 years, with the median follow-up estimated at 3.8 years. Study drugs will be mailed directly to participants every 90 days to support adherence, and telehealth enrollment options are available. Participants will undergo initial assessments including physical function tests and blood draws for lipid panels. Follow-up assessments will occur annually by phone to monitor cognitive and physical function, with in-person visits if needed. Cardiovascular events and other health outcomes will be tracked through electronic health records and national databases. The main outcomes measured include the number of participants without new diagnoses of dementia or persistent disability after 4 years. Safety and adherence are monitored through regular contact and data collection throughout the study period.