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Evaluating the effects of statins on older adults' health

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)

PHASE4 · Duke University · NCT04262206

This study is testing whether a cholesterol-lowering medication called atorvastatin can help older adults aged 75 and up stay healthier and avoid issues like dementia and disability.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment20000 (estimated)
Ages75 Years and up
SexAll
SponsorDuke University (other)
Locations103 sites (Birmingham, Alabama and 102 other locations)
Trial IDNCT04262206 on ClinicalTrials.gov

What this trial studies

This study is a multi-center, randomized, placebo-controlled trial that aims to assess the impact of atorvastatin 40 mg on community-dwelling adults aged 75 and older who do not have cardiovascular disease or dementia. Participants will be randomly assigned to receive either atorvastatin or a placebo and will be followed for up to 5 years to evaluate outcomes related to death, dementia, persistent disability, and mild cognitive impairment. The study will involve approximately 20,000 participants across 100 sites in the US, utilizing community engagement strategies for recruitment and retention.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling adults aged 75 years or older who do not have clinically evident cardiovascular disease or dementia.

Not a fit: Patients with clinically evident cardiovascular disease, significant disability, or dementia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for the use of statins in preventing cognitive decline and cardiovascular events in older adults.

How similar studies have performed: Other studies have explored statin use in older populations, but this specific approach focusing on cognitive impairment and disability prevention is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Community-dwelling adults
* Age ≥75 years
* English or Spanish as primary language
* Able to provide a trusted contact

Exclusion Criteria:

* 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

Where this trial is running

Birmingham, Alabama and 102 other locations

+53 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cognitive Impairment, Mild, Dementia, Cardiovascular Diseases, statin, older adults

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.