Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (NCT02719327) | Clinical Trial Compass
CompletedPhase 2/3
Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid
United States131 participantsStarted 2017-06-08
Plain-language 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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regional Cerebral Blood Flow Using Arterial Spin-labeling MRI