DHA Brain Delivery Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Delivery of Essential Fatty Acids to the Brain

Conditions
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Brain DHA Delivery and Alzheimer's Disease Risk

Intervention / Treatment
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* Drug: DHA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 55 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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind and randomized placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA<br>oral DHA supplementation at 2 grams per day | Drug: DHA<br>* DHA supplementation<br>|
| Placebo Comparator: Placebo<br>Placebo for DHA | Drug: Placebo<br>* Placebo for DHA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects | cerebrospinal fluid fatty acids assessed by mass spectrometry | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Docosahexaenoic Acids, Apolipoprotein E4