AzTrials
AzTrials

Cognitive Impairment, MildPhase 4PREVENTABLENCT04262206

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

A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Cognitive Impairment, Mild and Dementia, run by Duke University at 106 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
What is being tested?
Atorvastatin 40 Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20,000 participants
Where
106 sitesin 2 countries
Study dates
1 Sep 2020to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

106 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pamela Monds contact

9196688695

pamela.monds@duke.edu

Beth Harris contact

9196688700

Elizabeth.C.Harris@duke.edu

106 sites in 2 countries

United States104 sites, 92 recruiting

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

    Mariam Toma, 734-883-0016, mariam.toma@va.gov

    Pearl Lee

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Martina Nabozny, 734-385-6150, mgrenier@med.umich.edu

    Pearl Lee

    Recruiting

  • Asheville VA-Charles George VA Medical Center

    Asheville, North Carolina, 28805

    Kathleen Betts, 828-298-7911 ext. 15230, kathleen.betts@va.gov

    Brian Peek

    Recruiting

  • Atlanta VA Medical Center

    Atlanta, Georgia, 30033

    Mechelle Lockhart, 404-315-4100 ext. 373125, Mechelle.lockhart@va.gov

    Camille Vaughan

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    William Brown, 770-330-7790, mindandheart@emory.edu

    Ambar Kulshreshtha, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Megan Gauvey-Kern, 443-242-4126, PREVENTABLE@jhmi.edu

    Daniel Ford

    Recruiting

  • Bay Pines VA

    Bay Pines, Florida, 33744

    Anna Rosenblatt, 727-398-6661 ext. 17051, anna.rosenblatt2@va.gov

    Manjunath Harlapur

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Destiny Taylor, 205-224-2567, destiny.taylor@uabmc.edu

    Tanja Dudenbostel, MD

    Recruiting

  • Birmingham VA

    Birmingham, Alabama, 35233

    Donald Davis, 205-933-8101 ext. 334529, Donald.Davis@va.gov

    Elizabeth Jackson

    Recruiting

  • VA Boston Healthcare System

    Boston, Massachusetts, 02130

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

    Ariela Orkaby

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Jeannie Ake, 919-966-9003, UNC_PREV@office.unc.edu

    David Lynch

    Recruiting

  • Charleston VA Medical Center

    Charleston, South Carolina, 29401

    Alycia Blair, 843-829-2110 ext. 1011, alycia.blair@va.gov

    Fernandes Jyotika

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

    Amy Reynolds, 843-792-8459, muscpreventable@musc.edu

    Leslie Lenert

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28207

    Kelsey Strout, 704-304-8394, preventablestudy@atriumhealth.org

    Lindsay Shade

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60208

    Holly Herman, 312-503-4639, holly.herman@northwestern.edu

    Jeff Linder

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

    Naomi Ashley, 1-312-355-0083, naomiab@uic.edu

    Howard Gordon

    Recruiting

  • Chicago VA Medical Center/Jesse Brown VA

    Chicago, Illinois, 60612

    Naomi Ashley, 312-569-7339, naomi.ashley@va.gov

    Howard S Gordon

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Erin Yurko, 312-942-6596, erin_yurko@rush.edu

    Raj Shah

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Matt Carlson, 210-908-7749, mcarlson1@medicine.bsd.uchicago.edu

    Tamar Polonsky

    Recruiting

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

    Lora Morris, 513-861-3100 ext. 204417, Lora.Morris@va.gov

    Jack Rubinstein

    Recruiting

  • Clarksburg VA Medical Center

    Clarksburg, West Virginia, 26301

    Withdrawn

  • Case Western Reserve University

    Cleveland, Ohio, 44106

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

    Goutham Rao

    Recruiting

  • University of Missouri Health System

    Columbia, Missouri, 65212

    Vickie Grieshaber, 833-499-1938, mupreventable@health.missouri.edu

    Kristin Hahn-Cover

    Recruiting

  • Columbia VA Health Care System/Dorn VA Medical Center

    Columbia, South Carolina, 29209

    Ayanna Woolridge, 803-776-4000 ext. 54083, ayanna.woolridge@va.gov

    Andres Munoz

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Tait Palm, 614-685-3089, preventable@osumc.edu

    Seuli Brill

    Recruiting

  • Baylor Scott and White Medical Center

    Dallas, Texas, 75210

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

    Katherine Sanchez

    Recruiting

  • Dallas VA Medical Center

    Dallas, Texas, 75216

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

    Kyaw Soe

    Recruiting

  • University of Texas Southwestern Medical Center Dallas

    Dallas, Texas, 75390

    Gentina Thompson, 214-648-0205, gentina.thompson@utsouthwestern.edu

    Craig Rubin

    Recruiting

  • Dayton VA Medical Center

    Dayton, Ohio, 45428

    Cassie Pacer, 937-268-6511 ext. 2334, cassie.pacer@va.gov

    Ankur Gupta

    Recruiting

  • Essentia Health

    Duluth, Minnesota, 55805

    Leah Tatalovich, 218-576-0506, PREVENTABLE@EssentiaHealth.org

    Catherine Benzinger

    Recruiting

  • PREVENTABLE Tele-Site

    Durham, North Carolina, 27701

    Khaula Baloch

    Kristin Newby

    Recruiting

  • Durham VA Medical Center

    Durham, North Carolina, 27705

    Completed

  • Duke University

    Durham, North Carolina, 27710

    Trina Phan, 919-684-9176, DukePREVENTABLE@duke.edu

    Ranee Chatterjee Montgomery

    Recruiting

  • Mayo Clinic Health Systems - NW Wisconsin

    Eau Claire, Wisconsin, 54703

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

    Steven Rosas

    Recruiting

  • Doctors Hospital at Renaissance

    Edinburg, Texas, 78539

    Esmeralda Cardosa-Mendoza, 956-362-2391, e.cardosa@dhr-rgv.com

    Juan Salazar, MD

    Recruiting

  • Fresno VA Medical Center

    Fresno, California, 93703

    Kieu Chau, 559-225-6100 ext. 4114, Kieu.chau@va.gov

    Sudeshna Kundu

    Recruiting

  • Gainesville VA Medical Center

    Gainesville, Florida, 32608

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

    Sriram Peruvemba

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Monika Guirguis, 352-273-5919, recruit@aging.ufl.edu

    Stephen Anton

    Recruiting

  • Hines VA Medical Center

    Hines, Illinois, 60141

    Holly Kramer, MD, 708-202-8387 ext. 21397, Holly.Kramer@va.gov

    Holly Kramer

    Recruiting

  • University of Texas at Houston

    Houston, Texas, 77204

    Paola Robles, 713-500-7904, paola.roblescordova@uth.tmc.edu

    Jessica Lee, MD

    Recruiting

  • Indianapolis VA Medical Center

    Indianapolis, Indiana, 46202

    Jared Ferguson, 317-988-9833, jared.ferguson2@va.gov

    James Walsh

    Recruiting

  • University of Iowa Healthcare

    Iowa City, Iowa, 52242

    Samantha Shaffer, 319-678-7053, samantha-shaffer@uiowa.edu

    Michael Ernst

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Lane Boyer, 601-815-8702, kboyer@umc.edu

    Michael Hall

    Recruiting

  • VA Medical Center Jackson

    Jackson, Mississippi, 39216

    Anita K Spencer, 601-362-4471 ext. 51126, anita.spencer@va.gov

    Anita Basu

    Recruiting

  • University of Florida

    Jacksonville, Florida, 32608

    Renae Burr, 904-244-4690, JAX-ASCENT@jax.ufl.edu

    Stephen Anton

    Recruiting

  • Duke University - Kannapolis

    Kannapolis, North Carolina, 28081

    Jennifer Stiller, 704-640-7616, preventable-kannapolis@dm.duke.edu

    Ranee Chatterjee

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Erica Lower, 913-588-6052, elower@kumc.edu

    Kristin Grdinovac

    Recruiting

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

    Shamsa Kiran, 816-861-4700 ext. 56044, Shamsa.Kiran@va.gov;

    Vikas Singh

    Recruiting

  • Mayo Clinic Health System SW Wisconsin

    La Crosse, Wisconsin, 54601

    Janel Tunison, 608-392-6880, tunison.janel@mayo.edu

    Thomas Loepfe

    Recruiting

  • Little Rock VA Medical Center

    Little Rock, Arkansas, 72114

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

    Kalpana Padala

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72204

    Patricia Savary, 501-5265701, PESavary@uams.edu

    Jeanne Wei, MD

    Recruiting

  • Long Beach VA Medical Center

    Long Beach, California, 90822

    Celine Kogane, 562-826-8000 ext. 13805, celine.kogane@va.gov

    Kenny Vu

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Sandy Joung, 424-315-2284, preventable-study@cshs.org

    Nicolas Musi, MD

    Not yet recruiting

  • VA Greater Los Angeles

    Los Angeles, California, 90073

    MIkayla Guerrero, 310-478-3711 ext. 41235, mikayla.guerrero@va.gov

    Cathy Lee

    Recruiting

  • Louisville VA Medical Center

    Louisville, Kentucky, 40206

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

    Sathya Krishnasamy

    Recruiting

  • Madison VA Medical Center

    Madison, Wisconsin, 53705

    Hannah Zylstra, 608-256-1901 ext. 17152, hannah.zylstra@va.gov

    Cynthia Carlsson

    Recruiting

  • University of Wisconsin at Madison

    Madison, Wisconsin, 53792

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

    Cynthia Carlsson, MD

    Recruiting

  • Northwell Health

    Manhasset, New York, 11030

    Julie DiGregorio, 516-493-7950, jdigregori@northwell.edu

    Joseph Conigliaro

    Recruiting

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

    Diane Kohnhorst, 888-367-4413, PREVENTABLE@marshfieldresearch.org

    Jeffrey Vanwormer

    Recruiting

  • VA Northern California Health Care System

    Mather, California, 95655

    Maria Spinelli, 925-895-5196, maria.spinelli@va.gov

    Ajay Sood

    Recruiting

  • VA Medical Center Memphis

    Memphis, Tennessee, 38104

    Completed

  • Miami VA Medical Center

    Miami, Florida, 33125

    Completed

  • University of Miami

    Miami, Florida, 33136

    Yesenia Levi, 786-877-7710, yxl878@miami.edu

    Olveen Carrasquillo

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53295

    Madeline Berendt, 414-805-7291, PREVENTABLE@mcw.edu

    Jake Decker

    Recruiting

  • Milwaukee VA Medical Center

    Milwaukee, Wisconsin, 53295

    Julie Lorscheter, 414-384-2000 ext. 46627, julie.lorscheter@va.gov

    Jeffrey Whittle

    Recruiting

  • Allina Health

    Minneapolis, Minnesota, 55407

    Active, not recruiting

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

    Withdrawn

  • VA Hudson Valley Healthcare System

    Montrose, New York, 10548

    Withdrawn

  • Intermountain

    Murray, Utah, 84107

    Tyler Winslow, 801-507-4565, preventablestudy@imail.org

    Kirk Knowlton

    Recruiting

  • Meharry Medical College

    Nashville, Tennessee, 37208

    Steven Houtschilt, 615-398-2741, shoutschilt@mmc.edu

    Richmond Akatue

    Recruiting

  • Nashville VA Medical Center

    Nashville, Tennessee, 37212

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

    Christianne Roumie

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Jennifer Wharton, 615-322-6191, jennifer.wharton@vumc.org

    Amanda Mixon

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Meilyn Madrigal, 203-737-2252, meilyn.madrigal@yale.edu

    Thomas Gill

    Recruiting

  • University Medical Center

    New Orleans, Louisiana, 70112

    Completed

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Shannon Williams, 504-842-6487, slwilliams@ochsner.org

    Lydia Bazzano

    Recruiting

  • VA New York Harbor Healthcare System

    New York, New York, 10010

    Natalie Nejaime, 212-951-3395, natalie.nejaime@va.gov

    Sundar Natarajan

    Recruiting

  • Weill Cornell Medical College

    New York, New York, 10021

    Fernando Park, 607-204-9070, preventable@med.cornell.edu

    Parag Goyal

    Recruiting

  • North Chicago VA Medical Center

    North Chicago, Illinois, 60064

    Erica Noel, 224-610-7140, erica.noel@va.gov

    Raul J Gazmuri

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 67105

    Amy Peterson, 1-402-552-7737, preventable@unmc.edu

    Alfred Fisher

    Recruiting

  • Omaha VA Medical Center

    Omaha, Nebraska, 68105

    Ari Bader, 402-552-7737, ari.bader@va.gov

    Alfred Fisher

    Recruiting

  • VA Palo Alto Healthcare System

    Palo Alto, California, 94550

    Withdrawn

  • Corporal Michael J. Crescenz VA Medical Center-Philadelphia VA

    Philadelphia, Pennsylvania, 19104

    Withdrawn

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    William Leach, 636-253-7191, William.Leach@jefferson.edu

    Christopher Chambers

    Not yet recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Emily Klawson, 412-586-9796, klawson2@upmc.edu

    Daniel Forman

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Matthew Howard, 503-494-1583, howamat@ohsu.edu

    Elizabeth Eckstrom

    Not yet recruiting

  • Providence VA Medical Center

    Providence, Rhode Island, 002908

    Sarah Richer, 401-273-7100 ext. 16465, sarah.richter@va.gov

    Gaurav Choudhary

    Recruiting

  • Reno VA/Sierra Nevada Health Care

    Reno, Nevada, 89502

    Withdrawn

  • McGuire VA Medical Center

    Richmond, Virginia, 23219

    Charmaine Taylor, 804-675-5000 ext. 17301, charmaine.taylor@va.gov

    Michael Godschalk

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Angela Meilander, 507-293-9539, RSTPREVENTSTUDY@mayo.edu

    Alanna Chamberlain

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Active, not recruiting

  • VA Salt Lake City Healthcare System

    Salt Lake City, Utah, 84148

    Cosette Pryor, 385-580-3966, cosette.pryor@va.gov

    Amy Cowan

    Recruiting

  • San Antonio VA Medical Center

    San Antonio, Texas, 78229

    Kristy Michalek, 210-617-5900 ext. 116210, kristy.michalek@va.gov

    Marcos Restrepo

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Kevin Brown, 210-450-3045, Brownk5@uthscsa.edu

    Nicolas Musi

    Recruiting

  • VA San Diego Medical Center

    San Diego, California, 92161

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

    William Penny

    Recruiting

  • St. Louis VA Medical Center

    St Louis, Missouri, 63106

    Maureen Dempsey, 314-750-1591, maureen.dempsey@va.gov

    Jaifu Ou

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63130

    Amy Young, 314-273-0338, amyyoung@wustl.edu

    Ellen Binder, MD

    Recruiting

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

    Yessica E Vanterpool, 718-430-3422, yessica.estrellavanterpool@einsteinmed.edu

    Carlos Rodriguez

    Recruiting

  • Bronx VA Medical Center

    The Bronx, New York, 10468

    Raynier Baez, 718-584-9000 ext. 6099, raynier.baezguerrero@va.gov

    Matthew Augustine

    Recruiting

  • Maine VA Health Care System

    Togus, Maine, 04330

    Houlton Boomer, 207-623-8411 ext. 2592, houlton.boomer@va.gov

    David Duchin

    Recruiting

  • VA Eastern Kansas Healthcare System

    Topeka, Kansas, 66622

    Karen Reuben-Hallock, 913-682-2000 ext. 64167, Karen.Reuben-Hallock@va.gov

    Alexander Hallock

    Recruiting

  • Southern Arizona VA Health Care System - Tucson

    Tucson, Arizona, 85723

    Sarah Miranda, (520)792-1450 ext. 15245, sarah.miranda1@va.gov

    Ann Marie Canelas

    Recruiting

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 006111

    Study Coordinator, 203-932-5711 ext. 2842

    Brian Malm

    Recruiting

  • Wake Forest Baptist Hospital-Cardiology

    Winston-Salem, North Carolina, 27157

    Sophia Dawson, 336-713-2338, sadawson@wakehealth.edu

    Michael Shapiro

    Recruiting

  • Wake Forest Hospital - Geriatrics

    Winston-Salem, North Carolina, 27157

    Jesus Betancourt, 336-713-8659, jbetanco@wakehealth.edu

    Ezequiel Zamora

    Recruiting

Other trials in United States

Puerto Rico2 sites, 2 recruiting

  • VA Caribbean Healthcare System

    San Juan, Puerto Rico, 00921

    William Rodriguez-Cintron, MD, 787-641-7582 ext. 110116, william.rodriguez@va.gov

    William Rodriguez-Cintron

    Recruiting

  • VA Carribbean Healthcare

    San Juan, Puerto Rico, 00921

    William Rodriguez-Cintron, MD, 787-641-7582 ext. 110116, williams.rodriguez@va.gov

    William Rodriguez-Cintron

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

PREVENTABLE will randomly assign atorvastatin 40 mg daily or matching placebo daily to approximately 20,000 community-dwelling adults 75 years of age or older without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years (estimated median of 3.8 years). The study will enroll participants from approximately 100 US sites. Community engagement efforts will leverage community groups and practices as collaborators for recruitment. We plan to partner with participants, caregivers, and clinicians in all aspects of the study. The enrolling sites are non-VA and VA sites. To assist in recruitment, sites will apply a study-specific cohort identification algorithm to their electronic health record to create a list of eligible participants based on study inclusion and exclusion criteria. The cohort identification will exclude individuals with clinically evident cardiovascular disease, significant disability, or dementia and other exclusions obtainable from data queries to define a potential cohort. Additionally, the PREVENTABLE CCC will provide a centralized support team to assist with recruitment and retention efforts. This includes mass mailings and/or phone calls to potential participants and a toll-free number for potential participants to call for information and pre-screening. Interested and potentially eligible participants will be referred to an enrolling site near them, if applicable, otherwise, they will be referred to the PREVENTABLE Telesite which is capable of enrolling English and Spanish-speaking participants across the U.S. remotely. Sites will screen potential participants to confirm eligibility and consent and randomize those interested in joining the study. Specifically related to dementia, the qualifying exclusion is a clinical diagnosis in the chart or clinician's assessment that dementia may be present.

Sites will enter contact information, mailing address for study drug, demographic information, height, weight, statin history (if any), Social Security Number, and aspects of the medical history not obtainable from EHR. In addition, a Short Physical Performance Battery (SPPB) and Activities of Daily Living (ADL) screen will be site-performed at baseline. SPPB will provide an objective assessment of function for understanding frailty and physical function of the enrolled population. Baseline lipid panel (core lab) and biospecimen samples will be obtained using the same blood draw for 20cc of blood. Blinded lipid testing will be performed at baseline on all participants (n=20,000) and repeated at 3 months in a random subset (n=2,000). Lipid panels will be sent to the PREVENTABLE Core Lab to maintain study blind. Future testing of lipid panels during routine clinical care will be actively discouraged, but other laboratory testing as indicated by clinical care is permitted. Sites will have the option for telehealth enrollment. Baseline SPPB and Biorepository Labs are not required, but encouraged.

As part of the study operations, with the rationale of providing patient centricity, ease of participation, and access for vulnerable and at risk participants, follow up will be performed by a central call center. The baseline and annual assessments performed centrally will include a phone screen for cognitive function (TICS-M) and physical function (Patient-reported Outcome Measurement Information System-Physical Function [PROMIS-PF]). After year 1, if baseline calls indicated by crossing pre-specified cutpoints, in-person assessments will be completed by trained and certified research staff at a mutually agreed upon time and a standardized interview of a knowledgeable informant. Cardiovascular event ascertainment will be via a systematic approach to data curation from the EHR, Medicare, and National Death Index. For convenience and compliance, the study pharmacy will mail a supply of study drug, sufficient for 90 days, directly to participants. This will start immediately after randomization and continue as long as the participant is on study drug.

Being tested
Atorvastatin 40 Mg Oral Tablet, Placebo oral tablet
Keywords
statin, older adults
Medical subject headings
Cognitive Dysfunction, Dementia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 40 Mg Oral TabletDrug

    Also called Lipitor

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

  • Placebo oral tabletDrug

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

Study groups in NCT04262206
Study groupRoleWhat they receive
atorvastatin 40mgExperimental40mg atorvastatin po qd from consent to study end
Receives: Drug: Atorvastatin 40 Mg Oral Tablet
PlaceboPlacebo comparatormatching placebo po qd from consent to study end
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients without diagnosis of new dementia

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

    Measured: 4 years

  2. Number of patients without of persistent disability

    Number of patients without chronic disability in each group

    Measured: 4 years

Secondary outcomes (2)

  1. Cardiovascular mortality measured as a composite of CV death, hospitalization for myocardial infarction/unstable angina, heart failure, stroke/TIA, or coronary revascularization

    Cardiovascular mortality is measured by a composite measure of multiple CV conditions.

    Measured: 4 years

  2. Cognitive disability as measured as a composite of MCI or probable dementia

    Cognitive disability is measured by a composite of having mild cognitive impairment or probable dementia.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized 1:1 atorvastatin 40mg vs. placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262206
Sponsor's protocol ID
Pro00103844
Other IDs
1U19AG065188-01
Acronym
PREVENTABLE
Status last verified
Jun 2026
First submitted
7 Feb 2020
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Speiser JL, Ambrosius WT, Pajewski NM. Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials. Clin Trials. 2023 Oct;20(5):507-516. doi: 10.1177/17407745231177046. Epub 2023 May 26.

    PubMed 37243355

  • Joseph J, Pajewski NM, Dolor RJ, Sellers MA, Perdue LH, Peeples SR, Henrie AM, Woolard N, Jones WS, Benziger CP, Orkaby AR, Mixon AS, VanWormer JJ, Shapiro MD, Kistler CE, Polonsky TS, Chatterjee R, Chamberlain AM, Forman DE, Knowlton KU, Gill TM, Newby LK, Hammill BG, Cicek MS, Williams NA, Decker JE, Ou J, Rubinstein J, Choudhary G, Gazmuri RJ, Schmader KE, Roumie CL, Vaughan CP, Effron MB, Cooper-DeHoff RM, Supiano MA, Shah RC, Whittle JC, Hernandez AF, Ambrosius WT, Williamson JD, Alexander KP; PREVENTABLE Trial Research Group. Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale. J Am Geriatr Soc. 2023 Jun;71(6):1701-1713. doi: 10.1111/jgs.18312. Epub 2023 Apr 20.

    PubMed 37082807

  • Rozing MP, Westendorp RGJ. Altered cardiovascular risk pattern of LDL cholesterol in older adults. Curr Opin Lipidol. 2023 Feb 1;34(1):22-26. doi: 10.1097/MOL.0000000000000859. Epub 2022 Nov 16.

    PubMed 36413436

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Cognitive Impairment, Mild and Dementia, run by Duke University at 106 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pamela Monds (9196688695, pamela.monds@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients without diagnosis of new dementia (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262206, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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