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NCT02719327 · ClinicalTrials.gov registry record · Phase 2
Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT02719327: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT02719327 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02719327, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study 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.
Primary Outcome
For the primary outcome we chose an anatomical region, posterior cingulate gyrus, that aligned with statistical region of interest sensitive to changes in cerebral blood flow in cognitively-unimpaired adults at risk for Alzheimer's disease. Brain blood flow was averaged across the right and left posterior cingulate gyrus.
Interventions
- DRUG icosapent ethyl (IPE)
- OTHER gel cap placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
What the finished NCT02719327 record still lists
NCT02719327 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which icosapent ethyl (IPE) is the first listed.
NCT02719327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02719327 about?
NCT02719327 is a clinical study titled "Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid". 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 vasc...
What is the current status of trial NCT02719327?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2017-06-08. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT02719327?
The interventions under investigation include: icosapent ethyl (IPE) (DRUG), gel cap placebo (OTHER).
Who is sponsoring clinical trial NCT02719327?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02719327's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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