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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

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.

Eligible Conditions
  • Alzheimer's Disease

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Regional cerebral blood flow using arterial spin-labeling MRI
Secondary study objectives
Cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease
cognitive performance

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,466 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,231 Previous Clinical Trials
3,199,754 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
~16 spots leftby Dec 2025
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