DHA Brain Delivery Trial (PreventE4)

June 5, 2024 updated by: Hussein Yassine, University of Southern California

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA
oral DHA supplementation at 2 grams per day
Drug: DHA
DHA supplementation
Placebo Comparator: Placebo
Placebo for DHA
Drug: Placebo
Placebo for DHA

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional connectivity using resting state functional MRI in all 368 participants
Time Frame: 2 years
Functional Connectivity
2 years
Change in structural connectivity using MRI in all 368 participants
Time Frame: 2 years
Structural connectivity
2 years
Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants
Time Frame: 2 years
RBANS battery
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute on Aging (NIA)
Alzheimer's Drug Discovery Foundation
Huntington Medical Research Institutes

Investigators

  • Principal Investigator: Hussein Yassine, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

May 16, 2024

Study Completion (Actual)

May 16, 2024

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-18-00291/00984
  • R01AG054434 (U.S. NIH Grant/Contract)
  • GC-201711-2014197 (Other Grant/Funding Number: Alzheimer's Drug Discovery Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

available by request to study principal investigator and after approval by study committee.

IPD Sharing Time Frame

within 1 year after study publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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