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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
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
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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,275 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,193 Previous Clinical Trials
3,161,738 Total Patients Enrolled
Cynthia M. Carlsson, MD MSPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not have any significant problems with thinking, memory, or decision-making abilities.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: icosapent ethyl (IPE)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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