Trials / Completed
CompletedNCT03613844
DHA Brain Delivery Trial
The Delivery of Essential Fatty Acids to the Brain
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 365 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. This information will help us identify the target population that could benefit from DHA supplementation to prevent cognitive decline.
Detailed description
The Brain DHA Delivery Trial will examine the effect of APOE genotype on the changes of cerebrospinal fluid (CSF) DHA to Arachidonic acid (AA) ratio in 184 cognitively healthy older individuals in response to DHA supplementation. Randomized clinical trials have yielded mixed results on the effect DHA supplementation on cognitive outcomes. This study asks the critical question of whether DHA gets into the brain in sufficient amounts after supplementation, and whether APOE genotype affects brain penetrance. This trial will also test the effect of DHA supplementation on changes in brain structural and functional connectivity assessed by MRI, and changes in cognition after two years of supplementation in all 368 participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DHA | DHA supplementation |
| DRUG | Placebo | Placebo for DHA |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2024-05-16
- Completion
- 2024-05-16
- First posted
- 2018-08-03
- Last updated
- 2024-06-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03613844. Inclusion in this directory is not an endorsement.