DHA Brain Delivery Trial

Brain DHA Delivery and Alzheimer's Disease Risk Clinical Trial

— PreventE4  

Official title:

The Delivery of Essential Fatty Acids to the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613844
• Other study ID #: HS-18-00291/00984
• Secondary ID: R01AG054434GC-20
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: May 16, 2024

Study information

• Verified date: June 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: May 16, 2024
• Est. primary completion date: May 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain DHA Delivery and Alzheimer's Disease Risk

Intervention

Drug:
• DHA
DHA supplementation
• Placebo
Placebo for DHA

Locations

Country	Name	City	State
United States	USC Keck School of Medicine	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Alzheimer's Drug Discovery Foundation, Huntington Medical Research Institutes, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in functional connectivity using resting state functional MRI in all 368 participants	Functional Connectivity	2 years
Other	Change in structural connectivity using MRI in all 368 participants	Structural connectivity	2 years
Other	Change in cognitive measures using the Neuropsychological Outcomes (RBANS) in all 368 participants	RBANS battery	2 years
Primary	change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects	cerebrospinal fluid fatty acids assessed by mass spectrometry	6 months