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Trial record 1 of 1 for:    PREVENTE4 | Alzheimer Disease | United States
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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 : March 16, 2023
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain DHA Delivery and Alzheimer's Disease Risk Drug: DHA Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
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
Official Title: The Delivery of Essential Fatty Acids to the Brain
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Change in functional connectivity using resting state functional MRI in all 368 participants [ Time Frame: 2 years ]
    Functional Connectivity

  2. Change in structural connectivity using MRI in all 368 participants [ Time Frame: 2 years ]
    Structural connectivity

  3. Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants [ Time Frame: 2 years ]
    RBANS battery


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613844


Locations
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United States, California
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Huntington Medical Research Institutes
National Institute on Aging (NIA)
Alzheimer's Drug Discovery Foundation
Investigators
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Principal Investigator: Hussein Yassine, MD University of Southern California
More Information
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Publications:

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Responsible Party: Hussein Yassine, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03613844    
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 )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: available by request to study principal investigator and after approval by study committee.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: within 1 year after study publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hussein Yassine, University of Southern California:
Alzheimer's disease
Docosahexaenoic Acids
Apolipoprotein E4
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders