Name: Vascepa
Synonyms: Icosapent ethyl (IPE), Ethyl eicosapentaenoic acid (E-EPA), AMR101, Miraxion
Therapy Type: Small Molecule (timeline)
Target Type: Other (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2/3)
Approved for: Severe hypertriglyceridemia, and to lower risk of cardiovascular events in people with elevated triglycerides


Vascepa is a prescription formulation of omega-3 fat ethyl eicosapentaenoic acid (ethyl-EPA) purified from fish oil. Liquid-filled capsules are taken twice a day with food, at a dose of 4 g per day.

This drug is approved to lower triglycerides in adults with severe hypertriglyceridemia. Vascepa is also used along with statins to reduce risk of heart attack or stroke in people with more modestly elevated serum triglycerides, or in people with diabetes plus additional cardiovascular risk factors. In trials, side effects included increased risk of arrhythmia and bleeding events. The most common side effects were musculoskeletal pain, swelling of hands and legs, atrial fibrillation, and joint pain. Unlike DHA or fish oil supplements, Vascepa does not raise LDL (bad) cholesterol.

Clinical studies of omega-3 supplements for AD have yielded negative results. Daily DHA/EPA for six months did not slow cognitive decline in people with mild to moderate AD, although there was a benefit for subjects with very mild disease (Freund-Levi et al., 2006). In other trials, 1.5 years of daily DHA did not affect cognition in people with AD (Quinn et al., 2010), and three years of DHA/EPA had no effect on cognitive decline in older people with memory complaints (Andrieu et al., 2017). No AD study to date has tested EPA alone, or at a dose above 650 mg/day.

In a Phase 3 trial in 300 people with Huntington’s disease, 2 g per day of ethyl-EPA for six months did not improve motor symptoms (HD Study Group TREND-HD Investigators, 2008). Prior trials of EPA in depression, schizophrenia, and a cognition outcome measure in an age-related macular degeneration trial were negative, as well (Chew et al., 2015).


In a pilot study of 22 patients with mild to moderate AD, ethyl-EPA at 1 gram daily for 12 weeks did not alter cognitive decline, compared with a 12-week untreated baseline period (Boston et al., 2004).

In June 2017, scientists at the Veteran’s Administration and the University of Wisconsin, Madison, began a Phase 2/3 proof-of-concept prevention trial to assess the effects of Vascepa on brain amyloid and vasculature. The single-center study is enrolling 150 cognitively healthy military veterans, aged 50 to 75, to receive 4 g of Vascepa daily or matching placebo for 18 months. The primary endpoint is change in regional cerebral blood flow, measured by atrial spin-labeling MRI. Secondary endpoints are changes in CSF Aβ, total tau, and phospho-tau, and cognitive performance on the Preclinical Alzheimer’s Cognitive Composite (PACC). As a group, veterans have a higher prevalence of dementia risk factors such as head trauma, post-traumatic stress, and hypertension; however, the trial is not requiring that participants have specific AD risk factors such as family history or ApoE4. The study will run through November 2021.

Vascepa is being clinically evaluated primarily for lipid and cardiovascular disorders and colon cancer. For details on the Vascepa trial for Alzheimer’s disease, see

Last Updated: 07 Feb 2020


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Therapeutics Citations

  1. Docosahexaenoic acid (DHA)

Paper Citations

  1. . Ethyl-EPA in Alzheimer's disease--a pilot study. Prostaglandins Leukot Essent Fatty Acids. 2004 Nov;71(5):341-6. PubMed.
  2. . Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. Arch Neurol. 2006 Oct;63(10):1402-8. PubMed.
  3. . Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial. JAMA. 2010 Nov 3;304(17):1903-11. PubMed.
  4. . Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. Epub 2017 Mar 27 PubMed.
  5. Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study. Arch Neurol. 2008 Dec;65(12):1582-9. PubMed.
  6. . Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial. JAMA. 2015 Aug 25;314(8):791-801. PubMed.

External Citations

  2. Phase 3 trial

Further Reading


  1. . ω-3 fatty acids in the prevention of cognitive decline in humans. Adv Nutr. 2013 Nov;4(6):672-6. Epub 2013 Nov 6 PubMed.
  2. . Effects of omega-3 fatty acids on cognitive performance: a meta-analysis. Neurobiol Aging. 2012 Feb 3; PubMed.
  3. . Protective effects of prescription n-3 fatty acids against impairment of spatial cognitive learning ability in amyloid β-infused rats. Food Funct. 2011 Jul;2(7):386-94. PubMed.
  4. . Protective effects of prescription n-3 fatty acids against impairment of spatial cognitive learning ability in amyloid β-infused rats. Food Funct. 2011 Jul;2(7):386-94. PubMed.