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Omega-3 Fatty Acid
Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (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 month study visit
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 month study visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 month study visit
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
Side effects data
From 2023 Phase 2 & 3 trial • 131 Patients • NCT027193275%
Muscle pain
3%
Fall
2%
Itching
2%
Laparoscopic prostatectomy
2%
Aortic aneurysm
2%
Dehydration
2%
Constipation
2%
COVID19
2%
Hemorrhoids
2%
Surgery
2%
Cancer
2%
Sinus infection
2%
Pneumothorax
2%
Urinary tract infection
2%
Chest pain or tightness
2%
Headache
2%
Accident
2%
Distended bladder
2%
Cellulitus, eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Icosapent Ethyl (IPE)
Placebo
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
1,668 Previous Clinical Trials
3,765,735 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,237 Previous Clinical Trials
3,200,848 Total Patients Enrolled
Cynthia M. Carlsson, MD MSPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI
Media Library
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.