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DHA Brain Delivery Trial (PreventE4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613844
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : November 14, 2022
Sponsor:
Collaborators:
Huntington Medical Research Institutes
National Institute on Aging (NIA)
Alzheimer's Drug Discovery Foundation
Information provided by (Responsible Party):
Hussein Yassine, University of Southern California

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date November 14, 2022
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
change in cerebrospinal fluid fatty acid levels after the intervention [ Time Frame: 6 months ]
cerebrospinal fluid fatty acids assessed by mass spectrometry
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 2, 2022)
  • Change in functional connectivity using resting state functional MRI in all 368 participants [ Time Frame: 2 years ]
    Functional Connectivity
  • Change in structural connectivity using MRI in all 368 participants [ Time Frame: 2 years ]
    Structural connectivity
  • Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants [ Time Frame: 2 years ]
    RBANS battery
Original Other Pre-specified Outcome Measures
 (submitted: July 27, 2018)
  • Brain MRI [ Time Frame: 2 years ]
    Functional Connectivity
  • Brain MRI [ Time Frame: 2 years ]
    Structural connectivity
  • Congition [ Time Frame: 2 years ]
    RBANS battery
  • Cognition [ Time Frame: 2 years ]
    Cogtrack battery
 
Descriptive Information
Brief Title  ICMJE DHA Brain Delivery Trial
Official Title  ICMJE The Delivery of Essential Fatty Acids to the Brain
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
double blind and randomized placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Brain DHA Delivery and Alzheimer's Disease Risk
Intervention  ICMJE
  • Drug: DHA
    DHA supplementation
  • Drug: Placebo
    Placebo for DHA
Study Arms  ICMJE
  • Experimental: DHA
    oral DHA supplementation at 2 grams per day
    Intervention: Drug: DHA
  • Placebo Comparator: Placebo
    Placebo for DHA
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2022)
368
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
160
Estimated Study Completion Date  ICMJE May 1, 2025
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03613844
Other Study ID Numbers  ICMJE HS-18-00291/00984
R01AG054434 ( U.S. NIH Grant/Contract )
GC-201711-2014197 ( Other Grant/Funding Number: Alzheimer's Drug Discovery Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: available by request to study principal investigator and after approval by study committee.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: within 1 year after study publication
Current Responsible Party Hussein Yassine, University of Southern California
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Southern California
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Huntington Medical Research Institutes
  • National Institute on Aging (NIA)
  • Alzheimer's Drug Discovery Foundation
Investigators  ICMJE
Principal Investigator: Hussein Yassine, MD University of Southern California
PRS Account University of Southern California
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP