Evaluating the effects of statins on older adults' health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Birmingham VA
  Birmingham, Alabama, United States Recruiting
• Southern Arizona VA Health Care System - Tucson
  Tucson, Arizona, United States Recruiting
• Little Rock VA Medical Center
  Little Rock, Arkansas, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Fresno VA Medical Center
  Fresno, California, United States Recruiting

+56 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pamela Monds
• Email: pamela.monds@duke.edu
• Phone: 9196688695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.