DHA Brain Delivery Trial (PreventE4)

University of Southern California

Status and phase

Completed

Phase 2

Conditions

Brain DHA Delivery and Alzheimer's Disease Risk

Treatments

Drug: Placebo

Drug: DHA

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03613844

R01AG054434 (U.S. NIH Grant/Contract)

HS-18-00291/00984

GC-201711-2014197 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

365 patients

Sex

All

Ages

55 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.