Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults

CLNA-001-15S

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.

2017-06-08

2023-09-29

2023-09-29

Completed

Early phase I

131

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization of icosapent ethyl 4 g daily vs matching placebo', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 131, 'type': 'ACTUAL'}}

2023-12-11