131 Participants Needed

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

(BRAVE-EPA Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: VA Office of Research and Development
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of purified fish oil on middle-aged Veterans who are at higher risk for Alzheimer's. The study will see if this fish oil can improve brain blood flow, reduce harmful markers in the fluid around the brain and spine, and boost cognitive performance. If successful, this could delay Alzheimer's onset and improve life quality for Veterans.

Will I have to stop taking my current medications?

The trial requires a 3-month period without fish oil supplements before participating. Additionally, you cannot use medications that interact with icosapent ethyl or anticoagulants. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Who Is on the Research Team?

CM

Cynthia M. Carlsson, MD MS

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

Inclusion Criteria

United States Veteran eligible for VA care
Age 50-75 years, inclusive
You should not have any significant problems with thinking, memory, or decision-making abilities.

Exclusion Criteria

Current use of fish oil supplements (requires 3 month wash-out period)
Active liver disease with AST or ALT greater than twice the upper limit of normal
Elevated creatine kinase greater than twice the upper limit of normal
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive icosapent ethyl or placebo for 18 months to assess effects on brain blood flow, CSF biomarkers, and cognitive performance

18 months
Regular visits for MRI, CSF, and cognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • icosapent ethyl (IPE)
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: icosapent ethyl (IPE)Experimental Treatment1 Intervention
Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo
Group II: placeboPlacebo Group1 Intervention
Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+
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