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PREVENTABLE Study: Atorvastatin for Older Adults

This study, called PREVENTABLE, is looking at whether atorvastatin 40 mg (a common cholesterol-lowering drug) can help older adults who don't have heart disease or dementia. You would be randomly assigned to take either atorvastatin or a placebo (an inactive pill). Researchers want to see if this drug can prevent new cases of dementia or long-term disability over four years. They are also looking at whether it can prevent mild cognitive impairment (problems with memory or thinking) and heart-related issues. The study aims to enroll about 20,000 adults aged 75 and older who live in the community and speak English or Spanish. The current status of the study is unclear.

Study design
This is a large, randomized study where participants are assigned by chance to either atorvastatin 40 mg or a placebo. It plans to enroll about 20,000 participants.
What's involved
Participants will take a pill daily and be followed for up to 5 years, with an estimated average of 3.8 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years, with primary outcomes measured at 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04262206

Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults

Recruiting
PHASE4Ages 75+InterventionalPrevention
Duke University
~20,000 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Atorvastatin 40 Mg Oral TabletPlacebo oral tablet

At a glance

Recruiting sites
91 of 106 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients without diagnosis of new dementia
Measured over 4 years
+1 more outcome measured

Conditions

Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases

Explore related trials

Cardiovascular DisorderCognitive DysfunctionDementia

NCT04262206

Where you'd take part

This study runs at 106 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albert Einstein College of Medicine

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • Asheville VA-Charles George VA Medical Center

    Asheville, North Carolinastudy coordinator listed

    Recruiting

  • Atlanta VA Medical Center

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Atrium Health

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • Bay Pines VA

    Bay Pines, Floridastudy coordinator listed

    Recruiting

  • Baylor Scott and White Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Birmingham VA

    Birmingham, Alabamastudy coordinator listed

    Recruiting

  • Bronx VA Medical Center

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Pamela Monds
[email protected]
9196688695
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of patients without diagnosis of new dementia4 years

    Number of patients without diagnosis of new dementia in each group (placebo vs. atorvastatin)

  • Number of patients without of persistent disability4 years

    Number of patients without chronic disability in each group