NCT03613844

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

5.7 years

First QC Date

July 11, 2018

Last Update Submit

June 5, 2024

Conditions

Brain DHA Delivery and Alzheimer's Disease Risk

Keywords

Alzheimer's diseaseDocosahexaenoic AcidsApolipoprotein E4

Outcome Measures

Primary Outcomes (1)

  • change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects

    cerebrospinal fluid fatty acids assessed by mass spectrometry

    6 months

Other Outcomes (3)

  • Change in functional connectivity using resting state functional MRI in all 368 participants

    2 years

  • Change in structural connectivity using MRI in all 368 participants

    2 years

  • Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants

    2 years

Study Arms (2)

DHA

EXPERIMENTAL

oral DHA supplementation at 2 grams per day

Drug: DHA

Placebo

PLACEBO COMPARATOR

Placebo for DHA

Drug: Placebo

Interventions

DHADRUG

DHA supplementation

DHA
PlaceboDRUG

Placebo for DHA

Placebo

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • Yassine HN, Braskie MN, Mack WJ, Castor KJ, Fonteh AN, Schneider LS, Harrington MG, Chui HC. Association of Docosahexaenoic Acid Supplementation With Alzheimer Disease Stage in Apolipoprotein E epsilon4 Carriers: A Review. JAMA Neurol. 2017 Mar 1;74(3):339-347. doi: 10.1001/jamaneurol.2016.4899.

    PMID: 28114437BACKGROUND

  • Yassine HN, Arellanes IC, Mazmanian A, De La Cruz L, Martinez J, Contreras L, Kono N, Liu BS, Badie D, Bantugan MA, Grindon A, Urich T, D'Orazio L, Emmanuel BA, Chui HC, Mack WJ, Harrington MG, Braskie MN, Schneider LS. Baseline Findings of PreventE4: A Double-Blind Placebo Controlled Clinical Trial Testing High Dose DHA in APOE4 Carriers before the Onset of Dementia. J Prev Alzheimers Dis. 2023;10(4):810-820. doi: 10.14283/jpad.2023.77.

    PMID: 37874103DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hussein Yassine, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: double blind and randomized placebo controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2018

First Posted

August 3, 2018

Study Start

September 1, 2018

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
within 1 year after study publication

Locations

US(1)