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Statins

Atorvastatin for Preventing Dementia (PREVENTABLE Trial)

Phase 4

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥75 years

Must not have

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)

Dementia (clinically evident or previously diagnosed)

Timeline

Screening 0 days

Treatment 60 months

Follow Up 0 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will show whether atorvastatin can prevent death, dementia, and disability in older adults without cardiovascular disease or dementia.

Who is the study for?

This trial is for community-dwelling adults aged 75 or older who primarily speak English or Spanish. It's not for veterans, those with recent statin use, severe visual impairments, intolerance to statins, evident cardiovascular disease like past heart attacks or strokes, recent heart failure hospitalization, dependence on help for daily activities (except incontinence), inability to talk on the phone, active liver disease, certain medication users (colchicine/verapamil/diltiazem), or diagnosed dementia.

What is being tested?

The PREVENTABLE study tests if Atorvastatin 40 mg can prevent death, dementia and disability compared to a placebo in older adults without CVD or dementia. Participants are randomly assigned either the drug or a placebo tablet equally and monitored for cognitive health and cardiovascular events.

What are the potential side effects?

Atorvastatin may cause muscle pain or weakness, digestive issues like nausea and constipation; it can also affect liver enzymes which will be closely monitored during the trial due to potential liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 75 years old or older.

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I am 75 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack, stroke, heart surgery, or need medication to prevent heart disease.

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I have been diagnosed with or show clear signs of dementia.

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I need help with daily activities like bathing or dressing, but not with using the bathroom.

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I have severe hearing loss that makes phone calls difficult.

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I am unable to speak.

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My doctor says I can't take 40 mg of atorvastatin.

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I have an active liver condition.

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I regularly take colchicine, verapamil, or more than 240mg/day of diltiazem.

Timeline

Screening ~ 0 days1 visit

Treatment ~ 60 months0 visits

Follow Up ~ 0 days1 visit

Screening ~ 0 days

Treatment ~ 60 months

Follow Up ~0 days

This trial's timeline: 0 days for screening, 60 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients without diagnosis of new dementia

Number of patients without of persistent disability

Secondary study objectives

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

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