Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 11/17/2018 |
| Start Date: | June 8, 2017 |
| End Date: | November 30, 2021 |
| Contact: | Cynthia M Carlsson, MD MS |
| Email: | Cynthia.Carlsson@va.gov |
| Phone: | (608) 280-7000 |
Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults
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.
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.
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 with increased risk
for developing AD due to parental history of the disease and increased prevalence of
apolipoprotein E4 (APOE4) allele. 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.
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 with increased risk
for developing AD due to parental history of the disease and increased prevalence of
apolipoprotein E4 (APOE4) allele. 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.
Inclusion Criteria:
- Parental history of Alzheimer's disease
- 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
We found this trial at
1
site
Madison, Wisconsin 53705
Principal Investigator: Cynthia M. Carlsson, MD MS
Phone: 608-256-1901
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