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ALA-enriched Nutrition for Cognitive Decline in APOE4 Older Adults

This study is looking at whether a daily supplement of alpha-linolenic acid (ALA), found in flaxseed oil, can help improve memory and brain health in older adults. You might be able to join if you are 60 or older, have mild memory problems (Mild Cognitive Impairment or MCI), and carry at least one APOE4 gene (a gene linked to a higher risk of Alzheimer's disease). Researchers want to see if ALA can improve your overall thinking abilities and strengthen the blood-brain barrier (a protective layer around your brain) over six months. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is a randomized, double-blind, placebo-controlled pilot study. It will compare 20 participants receiving ALA to those receiving a placebo (corn oil).
What's involved
Participants will take either ALA or corn oil daily for six months. Cognitive function and blood-brain barrier integrity will be measured at the beginning and end of the study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months, with measurements taken at baseline and at the end of the six-month period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07392723

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

Recruiting
PHASE2Ages 60+InterventionalTreatment
Michal Schnaider Beeri, Ph.D.
~20 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Alpha-Linolenic Acid (2.6 g/day)Placebo Control Group

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in global cognitive (score) function
Measured over Baseline and 6 months
+2 more outcomes measured

Conditions

Cognitive Dysfunction
Alzheimer Disease
Blood-Brain Barrier
Apolipoprotein E, Deficiency or Defect of
Brain Aging
Fatty Acids, Omega-3

Explore related trials

Mild cognitive disorderAPOE*4 Allele

NCT07392723

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rutgers - Institute for Health

    New Brunswick, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michal Beeri, PHD · PRINCIPAL_INVESTIGATOR · Rutgers University

Who to contact

Claudio Mendes, MS
[email protected]
8489328412
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in global cognitive (score) functionBaseline and 6 months

    Change in global cognition score from baseline to 6 months measured by an average of the z-scores across a broad cognitive battery, will be compared between ALA and placebo groups.

  • Change in Blood-Brain Barrier Integrity - Permeability of the BBBBaseline and 6 months

    Blood-brain barrier (BBB) permeability will be assessed using the water exchange rate constant (Kw), derived from a validated motion-corrected diffusion-weighted pseudocontinuous arterial spin labeling (MCDW-pCASL) MRI sequence. Values will be extracted from whole-brain and region-specific areas, including hippocampus, dorsolateral frontal cortex, and parietal cortex. Changes from baseline to 6 months will be compared between ALA and placebo groups.

  • Levels of blood biomarkers of BBB Integritybaseline and 6 months

    Changes in protein levels in serum of: mfsd2a, s100B, and Glial Fibrillary Acidic Protein (GFAP) indicative of BBB function. Changes from baseline to 6 months will be compared between ALA and placebo groups.