20,000 seniors test if statins ward off dementia and disability

NCT ID NCT04262206

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This large study is testing whether taking atorvastatin (a statin) can help healthy adults aged 75 and older avoid dementia, disability, and death. Participants are randomly assigned to take either the drug or a placebo for several years. The goal is to see if this simple pill can prevent serious age-related problems in people without existing heart disease or dementia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction cardiovascular disorder prevention target dementia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Cognitive impairment, mild Dementia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

94 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Albert Einstein College of Medicine
RECRUITING

The Bronx, New York, 10461, United States
Allina Health
ACTIVE_NOT_RECRUITING

Minneapolis, Minnesota, 55407, United States
Asheville VA-Charles George VA Medical Center
RECRUITING

Asheville, North Carolina, 28805, United States
Atlanta VA Medical Center
RECRUITING

Atlanta, Georgia, 30033, United States
Atrium Health
RECRUITING

Charlotte, North Carolina, 28207, United States

Contact Email: •••••@•••••
Bay Pines VA
RECRUITING

Bay Pines, Florida, 33744, United States
Baylor Scott and White Medical Center
RECRUITING

Dallas, Texas, 75210, United States
Birmingham VA
RECRUITING

Birmingham, Alabama, 35233, United States
Bronx VA Medical Center
RECRUITING

The Bronx, New York, 10468, United States
Case Western Reserve University
RECRUITING

Cleveland, Ohio, 44106, United States
Cedars-Sinai Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Charleston VA Medical Center
RECRUITING

Charleston, South Carolina, 29401, United States
Chicago VA Medical Center/Jesse Brown VA
RECRUITING

Chicago, Illinois, 60612, United States
Cincinnati VA Medical Center
RECRUITING

Cincinnati, Ohio, 45220, United States
Clarksburg VA Medical Center
WITHDRAWN

Clarksburg, West Virginia, 26301, United States
Columbia VA Health Care System/Dorn VA Medical Center
RECRUITING

Columbia, South Carolina, 29209, United States
Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA
WITHDRAWN

Philadelphia, Pennsylvania, 19104, United States
Dallas VA Medical Center
RECRUITING

Dallas, Texas, 75216, United States
Dayton VA Medical Center
RECRUITING

Dayton, Ohio, 45428, United States
Doctors Hospital at Renaissance
RECRUITING

Edinburg, Texas, 78539, United States
Duke University
RECRUITING

Durham, North Carolina, 27710, United States
Duke University - Kannapolis
RECRUITING

Kannapolis, North Carolina, 28081, United States
Durham VA Medical Center
COMPLETED

Durham, North Carolina, 27705, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Essentia Health
RECRUITING

Duluth, Minnesota, 55805, United States
Fresno VA Medical Center
RECRUITING

Fresno, California, 93703, United States
Gainesville VA Medical Center
RECRUITING

Gainesville, Florida, 32608, United States
Hines VA Medical Center
RECRUITING

Hines, Illinois, 60141, United States
Indianapolis VA Medical Center
RECRUITING

Indianapolis, Indiana, 46202, United States
Intermountain
RECRUITING

Murray, Utah, 84107, United States

Contact Email: •••••@•••••
Johns Hopkins University
RECRUITING

Baltimore, Maryland, 21287, United States
Kansas City VA Medical Center
RECRUITING

Kansas City, Missouri, 64128, United States
Little Rock VA Medical Center
RECRUITING

Little Rock, Arkansas, 72114, United States
Long Beach VA Medical Center
RECRUITING

Long Beach, California, 90822, United States
Louisville VA Medical Center
RECRUITING

Louisville, Kentucky, 40206, United States
Madison VA Medical Center
RECRUITING

Madison, Wisconsin, 53705, United States
Maine VA Health Care System
RECRUITING

Togus, Maine, 04330, United States
Marshfield Clinic
RECRUITING

Marshfield, Wisconsin, 54449, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States

Contact Email: •••••@•••••
Mayo Clinic Health System SW Wisconsin
RECRUITING

La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health Systems - NW Wisconsin
RECRUITING

Eau Claire, Wisconsin, 54703, United States
McGuire VA Medical Center
RECRUITING

Richmond, Virginia, 23219, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53295, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29403, United States
Meharry Medical College
RECRUITING

Nashville, Tennessee, 37208, United States
Miami VA Medical Center
COMPLETED

Miami, Florida, 33125, United States
Milwaukee VA Medical Center
RECRUITING

Milwaukee, Wisconsin, 53295, United States
Minneapolis VA Health Care System
WITHDRAWN

Minneapolis, Minnesota, 55417, United States
Nashville VA Medical Center
RECRUITING

Nashville, Tennessee, 37212, United States
North Chicago VA Medical Center
RECRUITING

North Chicago, Illinois, 60064, United States
Northwell Health
RECRUITING

Manhasset, New York, 11030, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60208, United States
Ochsner Clinic Foundation
RECRUITING

New Orleans, Louisiana, 70121, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Omaha VA Medical Center
RECRUITING

Omaha, Nebraska, 68105, United States
Oregon Health and Science University
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
PREVENTABLE Tele-Site
RECRUITING

Durham, North Carolina, 27701, United States
Providence VA Medical Center
RECRUITING

Providence, Rhode Island, 002908, United States
Reno VA/Sierra Nevada Health Care
WITHDRAWN

Reno, Nevada, 89502, United States
Rush University Medical Center
RECRUITING

Chicago, Illinois, 60612, United States
San Antonio VA Medical Center
RECRUITING

San Antonio, Texas, 78229, United States
Southern Arizona VA Health Care System - Tucson
RECRUITING

Tucson, Arizona, 85723, United States
St. Louis VA Medical Center
RECRUITING

St Louis, Missouri, 63106, United States
Thomas Jefferson University
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
University Medical Center
COMPLETED

New Orleans, Louisiana, 70112, United States
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35205, United States
University of Arkansas for Medical Sciences
RECRUITING

Little Rock, Arkansas, 72204, United States
University of Chicago
RECRUITING

Chicago, Illinois, 60637, United States
University of Florida
RECRUITING

Gainesville, Florida, 32610, United States

Contact Email: •••••@•••••
University of Florida
RECRUITING

Jacksonville, Florida, 32608, United States
University of Illinois at Chicago
RECRUITING

Chicago, Illinois, 60608, United States
University of Iowa Healthcare
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center
RECRUITING

Jackson, Mississippi, 39216, United States
University of Missouri Health System
RECRUITING

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 67105, United States
University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Texas Health Science Center at San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
University of Texas Southwestern Medical Center Dallas
RECRUITING

Dallas, Texas, 75390, United States
University of Texas at Houston
RECRUITING

Houston, Texas, 77204, United States
University of Utah
ACTIVE_NOT_RECRUITING

Salt Lake City, Utah, 84132, United States
University of Wisconsin at Madison
RECRUITING

Madison, Wisconsin, 53792, United States
VA Ann Arbor Healthcare System
RECRUITING

Ann Arbor, Michigan, 48105, United States
VA Boston Healthcare System
RECRUITING

Boston, Massachusetts, 02130, United States
VA Caribbean Healthcare System
RECRUITING

San Juan, Puerto Rico, 00921, Puerto Rico
VA Carribbean Healthcare
RECRUITING

San Juan, Puerto Rico, 00921, Puerto Rico
VA Connecticut Healthcare System
RECRUITING

West Haven, Connecticut, 006111, United States
VA Eastern Kansas Healthcare System
RECRUITING

Topeka, Kansas, 66622, United States
VA Greater Los Angeles
RECRUITING

Los Angeles, California, 90073, United States
VA Hudson Valley Healthcare System
WITHDRAWN

Montrose, New York, 10548, United States
VA Medical Center Jackson
RECRUITING

Jackson, Mississippi, 39216, United States
VA Medical Center Memphis
COMPLETED

Memphis, Tennessee, 38104, United States
VA New York Harbor Healthcare System
RECRUITING

New York, New York, 10010, United States
VA Northern California Health Care System
RECRUITING

Mather, California, 95655, United States
VA Palo Alto Healthcare System
WITHDRAWN

Palo Alto, California, 94550, United States
VA Salt Lake City Healthcare System
RECRUITING

Salt Lake City, Utah, 84148, United States
VA San Diego Medical Center
RECRUITING

San Diego, California, 92161, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37212, United States
Wake Forest Baptist Hospital-Cardiology
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Wake Forest Hospital - Geriatrics
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Washington University in St. Louis
RECRUITING

St Louis, Missouri, 63130, United States
Weill Cornell Medical College
RECRUITING

New York, New York, 10021, United States
Yale University
RECRUITING

New Haven, Connecticut, 06520, United States

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