Actively Recruiting
Alpha Linolenic Acid-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults With Mild Cognitive Impairment: Targeting Cerebrovascular and Blood-brain Barrier Health
Led by Michal Schnaider Beeri, Ph.D. · Updated on 2026-02-06
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of alpha-linolenic acid (ALA) supplementation on brain function and vascular health in older adults aged 60 and above with mild cognitive impairment (MCI) who carry the APOE4 gene. This pilot randomized, double-blind, placebo-controlled trial aims to improve cognitive outcomes by enhancing the body's production of docosahexaenoic acid (DHA) from ALA, potentially supporting blood-brain barrier (BBB) integrity and brain vascular health in this high-risk group. The study addresses the limitations of direct DHA supplementation and highlights a need for safer, cost-effective therapies for dementia risk reduction. Participants will be randomly assigned to receive either 2.6 grams of ALA daily via flaxseed oil or an identical placebo of corn oil, both provided in 5 mL oral syringes taken each morning with food for six months. The study will compare cognitive function, BBB permeability, cerebral blood flow, brain vascular reactivity, and blood biomarkers related to BBB integrity and Alzheimer's disease processes between the groups. The design includes secondary assessments of episodic memory, executive function, and brain imaging measures. During the study, participants will undergo evaluations at the beginning and end of the six-month period, including cognitive testing, MRI scans to assess BBB and vascular health, and blood tests for fatty acid levels and biomarkers. Participants will also have a study partner to provide information about daily functioning. The trial includes monitoring for safety and adherence, with the goal of establishing groundwork for larger trials assessing ALA's potential to protect brain health in APOE4 carriers at risk for Alzheimer's dementia.
CONDITIONS
Brief 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 who can provide information about daily function
- 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 condition
- Active cancer treatment interfering with study 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take a daily oral supplement of either alpha-linolenic acid (ALA) or a placebo for six months to evaluate effects on cognitive function and brain health.
Baseline visit and 1 follow-up visit at 6 months
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
R
Rebecca West-Mortimer, PHD
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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