NCT04262206 Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
| NCT ID | NCT04262206 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Cognitive Impairment, Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20,000 participants in total. It began in 2020-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04262206 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Cognitive Impairment, Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04262206 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04262206 currently recruiting?
Yes, NCT04262206 is actively recruiting participants. Contact the research team at pamela.monds@duke.edu for enrollment information.
Where is the NCT04262206 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Tucson, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT04262206 clinical trial?
NCT04262206 is sponsored by Duke University. The trial plans to enroll 20,000 participants.