RecruitingPhase 2

ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults

United States20 participantsStarted 2025-01-12

Plain-language summary

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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 60 years or older * Have amnestic Mild Cognitive Impairment (MCI) - memory problems that do not interfere with daily life. * Carry at least one APOE4 gene allele (determined by a blood test). * Be fluent in English or Spanish. * Have a study partner (family member or friend) who can provide information about daily function. * Have the ability to give informed consent and comply with study visits and procedures. Exclusion Criteria: * A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease, schizophrenia, epilepsy, traumatic brain injury). * History of stroke or other major neurological condition. * Short life expectancy due to end-stage disease or other serious medical condition. * Active cancer treatment that could interfere 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 history of prostate cancer, regardless of remission status, OR a prostate-specific antigen (PSA) level \> 20 ng/mL at screening. * Use of experimental Alzheimer's treatments (e.g., amyloid monoclonal antibodies) unless on a stable regimen as confirmed by the treating physician.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in global cognitive (score) function

Timeframe: Baseline and 6 months

Change in Blood-Brain Barrier Integrity - Permeability of the BBB

Timeframe: Baseline and 6 months

Levels of blood biomarkers of BBB Integrity

Timeframe: baseline and 6 months

Trial details

NCT IDNCT07392723

SponsorMichal Schnaider Beeri, Ph.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Claudio Mendes, MS

8489328412 alastudy@njms.rutgers.edu

View on ClinicalTrials.gov More Cognitive Dysfunction trials