← Back to Search

Omega-3 Fatty Acid

icosapent ethyl (IPE) for Alzheimer's Disease (BRAVE-EPA Trial)

Phase 2 & 3

Waitlist Available

Led By Cynthia M. Carlsson, MD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

BRAVE-EPA Trial Summary

This trial will test whether a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE) can improve brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD.

Eligible Conditions

Alzheimer's Disease

BRAVE-EPA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Regional cerebral blood flow using arterial spin-labeling MRI

Secondary outcome measures

Cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease

cognitive performance

BRAVE-EPA Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Icosapent ethyl

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,472 Total Patients Enrolled

University of Wisconsin, MadisonOTHER

1,182 Previous Clinical Trials

3,167,256 Total Patients Enrolled

Cynthia M. Carlsson, MD MSPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI

Media Library

icosapent ethyl (IPE) (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT02719327 — Phase 2 & 3

Alzheimer's Disease Research Study Groups: placebo, icosapent ethyl (IPE)

Alzheimer's Disease Clinical Trial 2023: icosapent ethyl (IPE) Highlights & Side Effects. Trial Name: NCT02719327 — Phase 2 & 3

icosapent ethyl (IPE) (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02719327 — Phase 2 & 3

Frequently Asked Questions

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

Which type of patient would be most beneficial to enroll in this trial?

"The prerequisites for enrolment in this trial include a diagnosis of AD and being between the ages of 50-75. In total, the study is hoping to enroll 131 individuals."

Answered by AI

Will this research include patients that are elderly?

"This particular clinical trial only allows patients that are aged 50 to 75. Out of the 576 total clinical trials, this is one of the few that has such a specific age range. 23 other trials are available for individuals under 18 and 553 studies are available for patients over 65."

Answered by AI

Can we enroll in this experiment now?

"According to the latest update on clinicaltrials.gov, this study is no longer recruiting patients. It began on June 8th, 2017 and the most recent update was on October 6th, 2020. Although this study has completed recruitment, there are 562 other studies that are still looking for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

2017. "Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02719327.