Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      The proposed study is a proof-of-concept, randomized, placebo-controlled, double-blind,
      parallel-group clinical trial assessing the efficacy of 18 months of icosapent ethyl (IPE)
      therapy on magnetic resonance imaging (MRI), cerebrospinal fluid (CSF), and cognitive
      biomarkers for AD in 150 cognitively-healthy Veterans ages 50-75 years. The overarching goal
      of this trial is to assess whether icosapent ethyl beneficially affects intermediate
      physiological measures associated with onset of AD in order to evaluate whether larger,
      multi-site, longer-duration Alzheimer's prevention trials are warranted to assess more
      definitive clinical outcomes. The proposed study aims to: 1) investigate the effects of 18
      months of IPE vs. placebo on regional cerebral blood flow as measured by arterial
      spin-labeling MRI; 2) determine the impact of 18 months of IPE vs. placebo on CSF biomarkers
      of AD pathology; and 3) evaluate the effects of 18 months of IPE vs. placebo on cognitive
      performance.
    

Intervention name(s): icosapent ethyl (IPE); gel cap placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo; Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo
Other intervention name(s): Vascepa; Placebo
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomization of icosapent ethyl 4 g daily vs matching placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Alzheimer's disease; Cerebrospinal fluid; brain blood flow; cognition; icosapent ethyl; Vascepa; omega-3 fatty acids; eicosapentaenoic acid