DHA Brain Delivery Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 60 - 80 |
| Updated: | 3/14/2019 |
| Start Date: | July 1, 2018 |
| End Date: | September 30, 2024 |
| Contact: | Isabella Cordova, BS |
| Email: | isabella.cordova@med.usc.edu |
| Phone: | 323-489-4896 |
The Delivery of Essential Fatty Acids to the Brain
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.
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.
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 160 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 320 participants.
cerebrospinal fluid (CSF) DHA to Arachidonic acid (AA) ratio in 160 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 320 participants.
Inclusion Criteria:
- Age: ≥ 60 and ≤ 80
- At least one dementia risk factor (obesity, education years, hypertension,
hyperlipidemia)
- Mini-Mental State Examination (MMSE) ≥ 25
- Logical Memory II delayed recall score ≥ 6 and ≤ 18 .
Exclusion Criteria:
- Diagnosis of dementia as assessed by the investigator
- Use of omega-3 preparations in the last 3 months
- > 200 mg/day of DHA consumption using a validated questionnaire
- Use of donepezil, rivastigmine, galantamine and/or memantine
- Alcohol or drug abuse
- A concomitant serious disease such as active cancer treatment or HIV.
- Participation in a clinical trial in the last 30 days
- Use of anticoagulants such as Plavix or Coumadin or the newer generation blood
thinners.
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