NCT04262206 · Phase 4 · RECRUITING
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
PREVENTABLE is a large Phase 4 trial testing whether atorvastatin 40 mg — a common cholesterol-lowering statin — can reduce the combined risk of death, dementia, and disability in adults 75 and older who do not yet have heart disease or dementia. Phase 4 means the drug is already approved; this is studying whether it helps a new population. Researchers are also tracking mild cognitive impairment and cardiovascular events as secondary outcomes.
You may qualify if
- Community-dwelling adults
- Age ≥75 years
- English or Spanish as primary language
- Able to provide a trusted contact
You're excluded if
- Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin (clinician determined)
- Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure in the absence of recent hospitalization or clinically evident cardiovascular disease is not an exclusion)
- Dementia (clinically evident or previously diagnosed)
- Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)
- Severe hearing impairment (preventing phone follow up)
- Unable to talk (preventing phone follow up)
- Statin use in the past year or for longer than 5 years previously (participant reported)
- Ineligible to take atorvastatin 40 mg (clinician determined)
- Documented intolerance to statins
- Active Liver Disease
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-05