Actively Recruiting
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
Led by Michal Schnaider Beeri, Ph.D. · Updated on 2026-02-06
20
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. By targeting the endogenous synthesis of docosahexaenoic acid (DHA) through ALA supplementation, the investigators aim to overcome the limitations of direct DHA supplementation, particularly in APOE4 carriers who exhibit low brain DHA levels and impaired blood-brain barrier function. This innovative approach offers a safe, cost-effective, and easily implementable therapeutic strategy for older adults at high risk for Alzheimer's dementia, especially APOE4 carriers, addressing a critical need given the limited cognitive benefits and significant adverse events of current amyloid-clearing drugs in this population.
CONDITIONS
Official Title
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Have amnestic Mild Cognitive Impairment (MCI) with memory problems that do not interfere with daily life
- Carry at least one APOE4 gene allele confirmed by blood test
- Be fluent in English or Spanish
- Have a study partner (family member or friend) who can provide information about daily function
- Be able to give informed consent and comply with study visits and procedures
You will not qualify if you...
- Diagnosis of dementia or other brain diseases significantly affecting thinking or memory (e.g., Alzheimer's, Parkinson's, schizophrenia, epilepsy, traumatic brain injury)
- History of stroke or major neurological conditions
- Short life expectancy due to end-stage disease or serious medical conditions
- Active cancer treatment that may interfere with participation
- Allergy or sensitivity to flaxseed oil or corn oil
- Current use of flaxseed, flax oil, or fish oil supplements more than once per week
- MRI contraindications such as pacemakers, metallic implants, or severe claustrophobia
- Current or past prostate cancer or PSA level over 20 ng/mL at screening
- Use of experimental Alzheimer's treatments unless on a stable regimen confirmed by a physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rutgers - Institute for Health
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
C
Claudio Mendes, MS
CONTACT
R
Rebecca West-Mortimer, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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