Trials / Unknown
UnknownNCT01953705
n-3 PUFA for Vascular Cognitive Aging
Omega 3 PUFA for the Vascular Component of Age-related Cognitive Decline
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Accepted
Summary
Brain scans can help identify changes that appear to increase risk for cognitive decline and dementia. Some of these brain changes are thought to reflect actual damage to the small blood vessels that support normal brain function. This clinical trial will determine whether an omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting the small blood vessels in the brain over 3 years in older adults at high risk for cognitive decline and dementia of Alzheimer's type.
Detailed description
The main objective of this study is to determine if omega 3 PUFA can slow the accumulation of brain MRI derived white matter hyper-intensities (WMH) over 3 years in a population at risk for dementia. This trial is designed to collect preliminary data into the mechanism by which PUFA therapy operates on the brain with special attention to the vascular components. The randomized, double-blind and controlled trial will rigorously test PUFA effects versus a placebo in non-demented elders over 3 years. This biomarker based trial will enroll 100 elders. Aim 1 will assess PUFA effects on neuroimaging parameter changes. Aim 2 will assess PUFA effects on blood-based biomarkers of endothelial health, and Aim 3 will collect preliminary data on PUFA effects on neuropsychological and functional parameters with special attention to the executive and speed of processing skills and gait speed.
Conditions
- Age Related Cognitive Decline
- Alzheimer's Disease
- Vascular Dementia
- Endothelial Dysfunction
- Executive Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omega 3 PUFA | fish oil concentrate standardized to long chain n-3 PUFA content |
| DRUG | Placebo |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2020-12-01
- Completion
- 2021-06-01
- First posted
- 2013-10-01
- Last updated
- 2020-09-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01953705. Inclusion in this directory is not an endorsement.