Recruiting

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

Sponsor:

Duke University

Code:

NCT04262206

Conditions

Cognitive Impairment, Mild

Dementia

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

Interventions

Atorvastatin 40 Mg Oral Tablet

Placebo oral tablet

Study Details

Brief summary:

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

Conditions

Cognitive Impairment, Mild

Dementia

Cardiovascular Diseases

Study ID

NCT04262206

Start date

Sep 1, 2020

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: atorvastatin 40mg

40mg atorvastatin po qd from consent to study end

placebo comparator: Placebo

matching placebo po qd from consent to study end

Interventions

Atorvastatin 40 Mg Oral Tablet

To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

Placebo oral tablet

To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,

Primary outcome measure

Number of patients without diagnosis of new dementia [ Time Frame: 4 years ]
Number of patients without of persistent disability [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Pamela Monds

9196688695 pamela.monds@duke.edu

Beth Harris

9196688700 Elizabeth.C.Harris@duke.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Destiny Taylor

205-224-2567 destiny.taylor@uabmc.edu

Principal Investigator:

Tanja Dudenbostel, MD

Birmingham VA

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Donald Davis

205-933-8101 Donald.Davis@va.gov

Principal Investigator:

Elizabeth Jackson

Southern Arizona VA Health Care System - Tucson

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Sarah Miranda

(520)792-1450 sarah.miranda1@va.gov

Principal Investigator:

Ann Marie Canelas

Little Rock VA Medical Center

Recruiting

Little Rock, Arkansas, United States, 72114

Contacts

Bonnie Dawson

501-257-2523 Bonnie.Dawson2@va.gov

Principal Investigator:

Kalpana Padala

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Patricia Savary

501-5265701 PESavary@uams.edu

Principal Investigator:

Jeanne Wei, MD

Fresno VA Medical Center

Recruiting

Fresno, California, United States, 93703

Contacts

Kieu Chau

559-225-6100 Kieu.chau@va.gov

Principal Investigator:

Sudeshna Kundu

Long Beach VA Medical Center

Recruiting

Long Beach, California, United States, 90822

Contacts

Celine Kogane

562-826-8000 celine.kogane@va.gov

Principal Investigator:

Kenny Vu

VA Greater Los Angeles

Recruiting

Los Angeles, California, United States, 90073

Contacts

MIkayla Guerrero

310-478-3711 mikayla.guerrero@va.gov

Principal Investigator:

Cathy Lee

VA Northern California Health Care System

Recruiting

Mather, California, United States, 95655

Contacts

Maria Spinelli

925-895-5196 maria.spinelli@va.gov

Principal Investigator:

Ajay Sood

VA San Diego Medical Center

Recruiting

San Diego, California, United States, 92161

Contacts

Melissa St. John

858-642-1129 Melissa.St.John@va.gov

Principal Investigator:

William Penny

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Meilyn Madrigal

203-737-2252 meilyn.madrigal@yale.edu

Principal Investigator:

Thomas Gill

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 006111

Contacts

Study Coordinator

203-932-5711

Principal Investigator:

Brian Malm

Bay Pines VA

Recruiting

Bay Pines, Florida, United States, 33744

Contacts

Anna Rosenblatt

727-398-6661 anna.rosenblatt2@va.gov

Principal Investigator:

Manjunath Harlapur

Gainesville VA Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Laura Dixon

352-548-7707 Laura.dixon1@va.gov

Principal Investigator:

Sriram Peruvemba

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Monika Guirguis

352-273-5919 recruit@aging.ufl.edu

Principal Investigator:

Stephen Anton

University of Florida

Recruiting

Jacksonville, Florida, United States, 32608

Contacts

Renae Burr

904-244-4690 JAX-ASCENT@jax.ufl.edu

Principal Investigator:

Stephen Anton

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Yesenia Levi

786-877-7710 yxl878@miami.edu

Principal Investigator:

Olveen Carrasquillo

Atlanta VA Medical Center

Recruiting

Atlanta, Georgia, United States, 30033

Contacts

Mechelle Lockhart

404-315-4100 Mechelle.lockhart@va.gov

Principal Investigator:

Camille Vaughan

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

William Brown

770-330-7790 mindandheart@emory.edu

Principal Investigator:

Ambar Kulshreshtha, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Holly Herman

312-503-4639 holly.herman@northwestern.edu

Principal Investigator:

Jeff Linder

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Naomi Ashley

1-312-355-0083 naomiab@uic.edu

Principal Investigator:

Howard Gordon

Chicago VA Medical Center/Jesse Brown VA

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Naomi Ashley

312-569-7339 naomi.ashley@va.gov

Principal Investigator:

Howard S Gordon

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Erin Yurko

312-942-6596 erin_yurko@rush.edu

Principal Investigator:

Raj Shah

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Matt Carlson

210-908-7749 mcarlson1@medicine.bsd.uchicago.edu

Principal Investigator:

Tamar Polonsky

Hines VA Medical Center

Recruiting

Hines, Illinois, United States, 60141

Contacts

Holly Kramer, MD

708-202-8387 Holly.Kramer@va.gov

Principal Investigator:

Holly Kramer

North Chicago VA Medical Center

Recruiting

North Chicago, Illinois, United States, 60064

Contacts

Erica Noel

224-610-7140 erica.noel@va.gov

Principal Investigator:

Raul J Gazmuri

Indianapolis VA Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jared Ferguson

317-988-9833 jared.ferguson2@va.gov

Principal Investigator:

James Walsh

University of Iowa Healthcare

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Samantha Shaffer

319-678-7053 samantha-shaffer@uiowa.edu

Principal Investigator:

Michael Ernst

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Erica Lower

913-588-6052 elower@kumc.edu

Principal Investigator:

Kristin Grdinovac

VA Eastern Kansas Healthcare System

Recruiting

Topeka, Kansas, United States, 66622

Contacts

Karen Reuben-Hallock

913-682-2000 Karen.Reuben-Hallock@va.gov

Principal Investigator:

Alexander Hallock

Louisville VA Medical Center

Recruiting

Louisville, Kentucky, United States, 40206

Contacts

Jordan Ricks

502-287-5208 Jordan.Ricks@va.gov

Principal Investigator:

Sathya Krishnasamy

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Shannon Williams

504-842-6487 slwilliams@ochsner.org

Principal Investigator:

Lydia Bazzano

Maine VA Health Care System

Recruiting

Togus, Maine, United States, 04330

Contacts

Houlton Boomer

207-623-8411 houlton.boomer@va.gov

Principal Investigator:

David Duchin

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Megan Gauvey-Kern

443-242-4126 PREVENTABLE@jhmi.edu

Principal Investigator:

Daniel Ford

VA Boston Healthcare System

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Enzo Yaksic

617-637-5139 Enzo.Yaksic@va.gov

Principal Investigator:

Ariela Orkaby

VA Ann Arbor Healthcare System

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Mariam Toma

734-883-0016 mariam.toma@va.gov

Principal Investigator:

Pearl Lee

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Martina Nabozny

734-385-6150 mgrenier@med.umich.edu

Principal Investigator:

Pearl Lee

Essentia Health

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Leah Tatalovich

218-576-0506 PREVENTABLE@EssentiaHealth.org

Principal Investigator:

Catherine Benzinger

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Angela Meilander

507-293-9539 RSTPREVENTSTUDY@mayo.edu

Principal Investigator:

Alanna Chamberlain

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Lane Boyer

601-815-8702 kboyer@umc.edu

Principal Investigator:

Michael Hall

VA Medical Center Jackson

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Anita K Spencer

601-362-4471 anita.spencer@va.gov

Principal Investigator:

Anita Basu

University of Missouri Health System

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Vickie Grieshaber

833-499-1938 mupreventable@health.missouri.edu

Principal Investigator:

Kristin Hahn-Cover

Kansas City VA Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Shamsa Kiran

816-861-4700 Shamsa.Kiran@va.gov;

Principal Investigator:

Vikas Singh

St. Louis VA Medical Center

Recruiting

St Louis, Missouri, United States, 63106

Contacts

Maureen Dempsey

314-750-1591 maureen.dempsey@va.gov

Principal Investigator:

Jaifu Ou

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Amy Young

314-273-0338 amyyoung@wustl.edu

Principal Investigator:

Ellen Binder, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 67105

Contacts

Amy Peterson

1-402-552-7737 preventable@unmc.edu

Principal Investigator:

Alfred Fisher

Omaha VA Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Ari Bader

402-552-7737 ari.bader@va.gov

Principal Investigator:

Alfred Fisher

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Julie DiGregorio

516-493-7950 jdigregori@northwell.edu

Principal Investigator:

Joseph Conigliaro

VA New York Harbor Healthcare System

Recruiting

New York, New York, United States, 10010

Contacts

Natalie Nejaime

212-951-3395 natalie.nejaime@va.gov

Principal Investigator:

Sundar Natarajan

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Fernando Park

607-204-9070 preventable@med.cornell.edu

Principal Investigator:

Parag Goyal

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Yessica E Vanterpool

718-430-3422 yessica.estrellavanterpool@einsteinmed.edu

Principal Investigator:

Carlos Rodriguez

Bronx VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Raynier Baez

718-584-9000 raynier.baezguerrero@va.gov

Principal Investigator:

Matthew Augustine

Asheville VA-Charles George VA Medical Center

Recruiting

Asheville, North Carolina, United States, 28805

Contacts

Kathleen Betts

828-298-7911 kathleen.betts@va.gov

Principal Investigator:

Brian Peek

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Jeannie Ake

919-966-9003 UNC_PREV@office.unc.edu

Principal Investigator:

David Lynch

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Kelsey Strout

704-304-8394 preventablestudy@atriumhealth.org

Principal Investigator:

Lindsay Shade

PREVENTABLE Tele-Site

Recruiting

Durham, North Carolina, United States, 27701

Principal Investigator:

Kristin Newby

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Trina Phan

919-684-9176 DukePREVENTABLE@duke.edu

Principal Investigator:

Ranee Chatterjee Montgomery

Duke University - Kannapolis

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Jennifer Stiller

704-640-7616 preventable-kannapolis@dm.duke.edu

Principal Investigator:

Ranee Chatterjee

Wake Forest Baptist Hospital-Cardiology

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Sophia Dawson

336-713-2338 sadawson@wakehealth.edu

Principal Investigator:

Michael Shapiro

Wake Forest Hospital - Geriatrics

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jesus Betancourt

336-713-8659 jbetanco@wakehealth.edu

Principal Investigator:

Ezequiel Zamora

Cincinnati VA Medical Center

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Lora Morris

513-861-3100 Lora.Morris@va.gov

Principal Investigator:

Jack Rubinstein

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kelsey Ufholz

216-286-2212 Kelsey.Ufholz@uhhospitals.org

Principal Investigator:

Goutham Rao

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Tait Palm

614-685-3089 preventable@osumc.edu

Principal Investigator:

Seuli Brill

Dayton VA Medical Center

Recruiting

Dayton, Ohio, United States, 45428

Contacts

Cassie Pacer

937-268-6511 cassie.pacer@va.gov

Principal Investigator:

Ankur Gupta

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Emily Klawson

412-586-9796 klawson2@upmc.edu

Principal Investigator:

Daniel Forman

Providence VA Medical Center

Recruiting

Providence, Rhode Island, United States, 002908

Contacts

Sarah Richer

401-273-7100 sarah.richter@va.gov

Principal Investigator:

Gaurav Choudhary

Charleston VA Medical Center

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Alycia Blair

843-829-2110 alycia.blair@va.gov

Principal Investigator:

Fernandes Jyotika

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Amy Reynolds

843-792-8459 muscpreventable@musc.edu

Principal Investigator:

Leslie Lenert

Columbia VA Health Care System/Dorn VA Medical Center

Recruiting

Columbia, South Carolina, United States, 29209

Contacts

Ayanna Woolridge

803-776-4000 ayanna.woolridge@va.gov

Principal Investigator:

Andres Munoz

Meharry Medical College

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Steven Houtschilt

615-398-2741 shoutschilt@mmc.edu

Principal Investigator:

Richmond Akatue

Nashville VA Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Jennifer Wharton

615-873-6055 Jennifer.Wharton@va.gov

Principal Investigator:

Christianne Roumie

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Jennifer Wharton

615-322-6191 jennifer.wharton@vumc.org

Principal Investigator:

Amanda Mixon

Baylor Scott and White Medical Center

Recruiting

Dallas, Texas, United States, 75210

Contacts

Kionna Henderson

214-865-3196 Kionna.Henderson@BSWHealth.org

Principal Investigator:

Katherine Sanchez

Dallas VA Medical Center

Recruiting

Dallas, Texas, United States, 75216

Contacts

Jodie-Ann Clarke

(214)857-0393 Jodie-ann.clarke@va.gov

Principal Investigator:

Kyaw Soe

University of Texas Southwestern Medical Center Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Gentina Thompson

214-648-0205 gentina.thompson@utsouthwestern.edu

Principal Investigator:

Craig Rubin

Doctors Hospital at Renaissance

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Esmeralda Cardosa-Mendoza

956-362-2391 e.cardosa@dhr-rgv.com

Principal Investigator:

Juan Salazar, MD

University of Texas at Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Paola Robles

713-500-7904 paola.roblescordova@uth.tmc.edu

Principal Investigator:

Jessica Lee, MD

San Antonio VA Medical Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kristy Michalek

210-617-5900 kristy.michalek@va.gov

Principal Investigator:

Marcos Restrepo

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kevin Brown

210-450-3045 Brownk5@uthscsa.edu

Principal Investigator:

Nicolas Musi

Intermountain

Recruiting

Murray, Utah, United States, 84107

Contacts

Tyler Winslow

801-507-4565 preventablestudy@imail.org

Principal Investigator:

Kirk Knowlton

VA Salt Lake City Healthcare System

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Cosette Pryor

385-580-3966 cosette.pryor@va.gov

Principal Investigator:

Amy Cowan

McGuire VA Medical Center

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Charmaine Taylor

804-675-5000 charmaine.taylor@va.gov

Principal Investigator:

Michael Godschalk

Mayo Clinic Health Systems - NW Wisconsin

Recruiting

Eau Claire, Wisconsin, United States, 54703

Contacts

Joshua Druckrey

715-838-5831 Druckrey.Joshua@mayo.edu

Principal Investigator:

Steven Rosas

Mayo Clinic Health System SW Wisconsin

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Janel Tunison

608-392-6880 tunison.janel@mayo.edu

Principal Investigator:

Thomas Loepfe

Madison VA Medical Center

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Hannah Zylstra

608-256-1901 hannah.zylstra@va.gov

Principal Investigator:

Cynthia Carlsson

University of Wisconsin at Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Hannah Zylstra

(608)262-9647 hjzylstra@medicine.wisc.edu

Principal Investigator:

Cynthia Carlsson, MD

Marshfield Clinic

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Diane Kohnhorst

888-367-4413 PREVENTABLE@marshfieldresearch.org

Principal Investigator:

Jeffrey Vanwormer

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53295

Contacts

Madeline Berendt

414-805-7291 PREVENTABLE@mcw.edu

Principal Investigator:

Jake Decker

Milwaukee VA Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53295

Contacts

Julie Lorscheter

414-384-2000 julie.lorscheter@va.gov

Principal Investigator:

Jeffrey Whittle

More Information

Sponsor

Duke University

Last update posted

Sep 1, 2026

Last verified

Jun, 2026

Keywords

statin
older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-01.