Back to resultsDHA Brain Delivery Trial (PreventE4)
Primary Purpose
Brain DHA Delivery and Alzheimer's Disease Risk
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHA
Placebo
Sponsored by
About this trial
This is an interventional other trial for Brain DHA Delivery and Alzheimer's Disease Risk focused on measuring Alzheimer's disease, Docosahexaenoic Acids, Apolipoprotein E4
Eligibility 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.
Sites / Locations
- USC Keck School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DHA
Placebo
Arm Description
oral DHA supplementation at 2 grams per day
Placebo for DHA
Outcomes
Primary Outcome Measures
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
cerebrospinal fluid fatty acids assessed by mass spectrometry
Secondary Outcome Measures
Full Information
NCT ID
NCT03613844
First Posted
July 11, 2018
Last Updated
March 14, 2023
Sponsor
University of Southern California
Collaborators
Huntington Medical Research Institutes, National Institute on Aging (NIA), Alzheimer's Drug Discovery Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03613844
Brief Title
DHA Brain Delivery Trial
Acronym
PreventE4
Official Title
The Delivery of Essential Fatty Acids to the Brain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Huntington Medical Research Institutes, National Institute on Aging (NIA), Alzheimer's Drug Discovery Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain DHA Delivery and Alzheimer's Disease Risk
Keywords
Alzheimer's disease, Docosahexaenoic Acids, Apolipoprotein E4
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blind and randomized placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DHA
Arm Type
Experimental
Arm Description
oral DHA supplementation at 2 grams per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for DHA
Intervention Type
Drug
Intervention Name(s)
DHA
Intervention Description
DHA supplementation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for DHA
Primary Outcome Measure Information:
Title
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
Description
cerebrospinal fluid fatty acids assessed by mass spectrometry
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in functional connectivity using resting state functional MRI in all 368 participants
Description
Functional Connectivity
Time Frame
2 years
Title
Change in structural connectivity using MRI in all 368 participants
Description
Structural connectivity
Time Frame
2 years
Title
Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants
Description
RBANS battery
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein Yassine, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
28114437
Citation
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.
Results Reference
background
Learn more about this trial
DHA Brain Delivery Trial
We'll reach out to this number within 24 hrs