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New treatment option for Cognitive Impairment, Mild
Official title Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
ClinicalTrials.gov ID: NCT04262206
What this study is testing
What is Atorvastatin 40 Mg Oral Tablet?
Atorvastatin 40 Mg Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for cognitive impairment, mild.
Also referred to as Lipitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older. Healthy volunteers may be eligible.
You may be able to join if
- Community-dwelling adults
- Age ≥75 years
- English or Spanish as primary language
- Able to provide a trusted contact
You likely can't join if
- Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a...
- Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure in the absence of recent...
- 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)
See the full eligibility criteria
- Community-dwelling adults
- Age ≥75 years
- English or Spanish as primary language
- Able to provide a trusted contact
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Fresno, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- New Haven, Connecticut, United States
- West Haven, Connecticut, United States
- Bay Pines, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Hines, Illinois, United States
- North Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Fresno, California, United States; Long Beach, California, United States; Los Angeles, California, United States and 66 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.