Phase 3 N=131 Randomized Quadruple-blind Prevention

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02719327 ↗

Enrolled (actual)

131

Serious AEs

12.2%

Results posted

Nov 2024

Primary outcome: Primary: Regional Cerebral Blood Flow Using Arterial Spin-labeling MRI — 55.7; 54.5 mL/g/min — p=0.17

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: icosapent ethyl (IPE) (Drug); gel cap placebo (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Regional Cerebral Blood Flow Using Arterial Spin-labeling MRI	55.7; 54.5	0.17
SECONDARY Cerebrospinal Fluid (CSF) Biomarkers of Alzheimer's Disease	1281.7; 1244.6; 20.2; 18.8; 218.2; 208.0	.12
SECONDARY Cognitive Performance	0.455; 0.611	.48

Summary

The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02719327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.