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Omega-3 Fatty Acid in Veterans at Risk for Alzheimer's

Recruiting

This study will evaluate the effect of icosapent ethyl, a form of an omega-3 fatty acid found in fish oil, on cognitive performance and Alzheimer's-related biomarkers in cognitively healthy veterans at increased risk for Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 75 Years All Yes
June 8, 2017
November 30, 2021
150

  • Parental history of Alzheimer's disease
  • U.S. veteran eligible for care by U.S. Department of Veterans Affairs
  • Cognitively healthy

  • Dementia or mild cognitive impairment at screening evaluation
  • Current use of cholesterol-lowering medication or fish oil supplements (requires 3 month wash-out period)
  • Active liver disease
  • Elevated creatine kinase level greater than twice the upper limit of normal
  • Prior adverse reaction to statins or fish oil, or hypersensitivity to fish and/or shellfish
  • Pregnant, nursing, or planned pregnancy
  • Use of medications that interact with icosapent ethyl
  • Current use of anticoagulants or other investigational drug
  • History of significant heart disease or diabetes
  • Low-density lipoprotein cholesterol greater than or equal to 190 mg/dL or less than 80 mg/dL
  • Triglycerides greater than or equal to 500 mg/dL
  • Creatinine level greater than 1.8 mg/dL
  • Inability to undergo lumbar puncture or magnetic resonance imaging due to lumbar surgery, claustrophobia, pacemaker, or other reason
  • Consumption of more than 200 mg a day of omega-3 fatty acids in diet

Participants will take either a gel cap of icosapent ethyl (4 grams) daily or a placebo for 18 months. Icosapent ethyl is a form of the omega-3 fatty acid eicosapentaenoic, which is found in cold-water fish such as salmon. Researchers will measure the efficacy of the therapy on blood flow in the brain, levels of Alzheimer's-related proteins in cerebrospinal fluid, and cognitive performance to determine if the treatment could help delay the onset of Alzheimer's.

Name City State Zip Status Primary Contact
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison Wisconsin 53705 Recruiting Aaron F Heneghan, PhD
608-256-1901
Aaron.Heneghan@va.gov

VA Office of Research and Development

  • University of Wisconsin, Madison

Name Role Affiliation
Cynthia M. Carlsson, MD Principal Investigator William S. Middleton Memorial Veterans Hospital

Name Phone Email
Cynthia M. Carlsson 608-280-7000 cynthia.carlsson@va.gov
Elena G. Beckman 608-256-1901 elena.beckman@va.gov

NCT02719327

Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults