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PREVENTABLE

RecruitingPhase 4

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

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

Lead sponsor

Duke University

Asset

Atorvastatin

Listed sites

103

Recruiting sites

Enrollment

20,000

estimated

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥75

Primary endpoints

•Number of patients without diagnosis of new dementia•Number of patients without of persistent disability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1U19AG065188-01

NCT IDNCT04262206

Org study IDPro00103844

Timeline

Milestones

Study first posted2020-02-10actual

Study start2020-09-01actual

Last update posted2026-06-04actual

Primary completion2026-12-31estimated

Study completion2026-12-31estimated

Assets

Drug assets

Atorvastatin

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age75 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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

Time frame:4 years

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Number of patients without diagnosis of new dementia

Time frame:4 years

event count, event

Primary/protocol endpoint/low confidence

Number of patients without of persistent disability

Time frame:4 years

event count, event

Secondary/protocol endpoint/low confidence

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

Time frame:4 years

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.