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BRAVE-EPA

CompletedPhase 2 / PHASE3Results posted

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults

Lead sponsor

VA Office of Research and Development

Asset

icosapent ethyl (IPE)

Listed sites

Recruiting sites

Enrollment

131

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 50-75•MRI contraindications excluded•Current anticoagulant use excluded

Primary endpoint

•Regional Cerebral Blood Flow

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCLNA-001-15S

Other grantCX001261VA Merit

NCT IDNCT02719327

Timeline

Milestones

Study first posted2016-03-25estimated

Study start2017-06-08actual

Primary completion2023-09-29actual

Study completion2023-09-29actual

Last update posted2024-11-26actual

Results first posted2024-11-26actual

Assets

Drug assets

icosapent ethyl (IPE)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•United States Veteran eligible for VA care

•Age 50-75 years, inclusive

•Cognitively healthy

Exclusion criteria

•Dementia or mild cognitive impairment on screening evaluation

•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

•Prior adverse reaction to statins or fish oil

•Pregnant, nursing, or pregnancy planned

•Use of medications that interact with icosapent ethyl

•Current use of anticoagulants

•Known hypersensitivity to fish and/or shellfish

•Current use of other investigational drug

•History of significant atherosclerotic cardiovascular disease or diabetes mellitus

•Low-density lipoprotein (LDL) cholesterol > or =190 mg/dL or <80 mg/dL

•Triglycerides > or = 500 mg/dL

•Creatinine >1.8 mg/dL

•Previous lumbar surgery with contraindication to lumbar puncture

•Claustrophobia requiring sedation for MRI

•Pacemaker or other contraindication for MRI

•Consumption of >200 mg per day omega-3 fatty acids in diet

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Neuroimaging

Global cognition

2 endpoints

Secondary/protocol endpoint

Cognitive Performance

Time frame:18 month study visit

descriptive

Secondary/registry result

Cognitive Performance

Time frame:18 month study visit

descriptive

Posted result

Group	Value (mean), Z-score	Standard deviation
Icosapent Ethyl (IPE)n=52 Participants	0.455	1.22
Placebon=60 Participants	0.611	1.10

Slope0.00695% CI-0.009 - 0.023p.48Linear Mixed Effects model

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid (CSF) Biomarkers of Alzheimer's Disease

Time frame:18 month study visit

descriptive

Secondary/registry result

Cerebrospinal Fluid (CSF) Biomarkers of Alzheimer's Disease

Time frame:18 month study visit

descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
Icosapent Ethyl (IPE)beta-amyloid(1-42)n=41 Participants	1281.7	558.5
phosphorylated tau(181)n=41 Participants	20.2	8.13
Total taun=41 Participants	218.2	83.6
Placebobeta-amyloid(1-42)n=45 Participants	1244.6	607.7
phosphorylated tau(181)n=45 Participants	18.8	5.56
Total taun=45 Participants	208.0	63.7

Slope0.1195% CI-0.04 - 0.25p.12Regression, Linear

Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.

Slope0.04595% CI0.004 - 0.061p0.05Regression, Linear

Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.

Slope0.04695% CI-0.0008 - 0.106p.07Regression, Linear

Total tau was log-transformed prior to analysis to better approximate a normal distribution.

Neuroimaging

2 endpoints

Primary/protocol endpoint

Regional Cerebral Blood Flow Using Arterial Spin-labeling MRI

Time frame:18 month study visit

descriptive

Primary/registry result

Regional Cerebral Blood Flow Using Arterial Spin-labeling MRI

Time frame:18 month study visit

descriptive

Posted result

Group	Value (mean), mL/g/min	Standard deviation
Icosapent Ethyl (IPE)n=54 Participants	55.7	14.6
Placebon=60 Participants	54.5	14.1

Slope-2.1895% CI-5.36 - 0.99p0.17Regression, Linear

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.