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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
Community-dwelling adults
Timeline
Screening 3 weeks
Treatment 60 months
Follow Up 4 years
Awards & highlights

PREVENTABLE 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.Check my eligibility
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.See study design
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.

PREVENTABLE Trial 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 live in my own home or with family.
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I am 75 years old or older.
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My primary language is either English or Spanish.

PREVENTABLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ 60 months
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, 60 months for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients without diagnosis of new dementia
Number of patients without of persistent disability
Secondary outcome measures
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

PREVENTABLE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: atorvastatin 40mgExperimental Treatment1 Intervention
40mg atorvastatin po qd from consent to study end
Group II: PlaceboPlacebo Group1 Intervention
matching placebo po qd from consent to study end
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin 40 Mg Oral Tablet
2018
Completed Phase 4
~400

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,400,069 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
27,985,114 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,290,635 Total Patients Enrolled

Media Library

Atorvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT04262206 — Phase 4
Cardiovascular Disease Research Study Groups: Placebo, atorvastatin 40mg
Cardiovascular Disease Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04262206 — Phase 4
Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262206 — Phase 4
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT04262206 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions is Atorvastatin 40 Mg Oral Tablet most often utilized for?

"Atorvastatin 40 Mg Oral Tablet is an ideal remedy for lipidemias, postoperative thromboembolism and anginal pain."

Answered by AI

How many participants are the maximum capacity of this research endeavor?

"In order to have the desired impact, this clinical trial requires 20 thousand patients who meet eligibility criteria. Patients in Asheville VA-Charles George VA Medical Center (Asheville, NC) and Cincinnati VA Medical Center (Cincinnati, OH) are both invited to take part."

Answered by AI

How many locations are conducting this investigation?

"This trial is presently recruiting patients at a total of 74 distinct sites, including the Asheville VA-Charles George VA Medical Center, Cincinnati VA Medical Centre and Duke University in Durham."

Answered by AI

Have there been any past research projects that have focused on Atorvastatin 40 Mg Oral Tablet?

"OHSU Hospital first tested Atorvastatin 40 Mg Oral Tablet in 2005 and since then, 531 trials have been completed. Presently there are 70 active clinical trials taking place primarily in Asheville, North carolina."

Answered by AI

Has the Atorvastatin 40 Mg Oral Tablet been ratified by the federal regulatory agency?

"There is ample evidence of Atorvastatin 40 Mg Oral Tablet's safety, so it scored a 3 on our team's evaluation scale. This medication has already been approved for use in Phase 4 clinical trials."

Answered by AI

Has this innovative research ever been attempted before?

"Since 2005, research has been conducted on Atorvastatin 40 Mg Oral Tablet. 80 patients were involved in the initial study sponsored by Merck Sharp & Dohme LLC and this drug received its final approval from phase 4 trials. Currently, 70 studies are live for this medication across 162 cities and 28 countries worldwide."

Answered by AI

Are there any opportunities presently available to participate in this experiment?

"Affirmative. Per the details available on clinicaltrials.gov, this healthcare trial is presently recruiting participants and was first announced to the public on September 1st 2020. 20000 individuals are needed for enrolment across 74 distinct medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Texas
Illinois
Other
How old are they?
65+
What site did they apply to?
University of Chicago
VA Boston Healthcare System
University of Texas at Houston
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

To try and improve my health. I need to hear more about this statin. Learning disabled with TBI from childhood.
PatientReceived 1 prior treatment
I just started taking this drug last month.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

how long is this study? How long do the trial periods last? Positive previous results and is this a paid study?
PatientReceived 1 prior treatment
Yes. How often and how long are study visits? Is there a compensation? How many visits. Any over night. How long are visits. Is transportation available in case my car is unavailable. What is compensation. ? How long do you admiration of drug to me for completion?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. University of Chicago: < 24 hours
  2. Rush University Medical Center: < 48 hours
Average response time
  • < 2 Days
~7536 spots leftby Jun 2026