ALA-enriched nutrition to prevent cognitive decline in older adults with APOE4
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
This study will test whether taking daily alpha-linolenic acid (ALA) supplements can slow cognitive decline and improve brain blood-vessel and barrier health in older adults with mild cognitive impairment who carry the APOE4 gene.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT07392723 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 2 pilot trial enrolling 60 older adults (age ≥60) with amnestic mild cognitive impairment who carry at least one APOE4 allele. Participants will be randomized to receive either 2.6 g/day of ALA (from flaxseed oil) or a placebo (corn oil) for six months, with both participants and staff blinded to assignment. Primary outcomes include change in global cognition and MRI measures of blood-brain barrier integrity and brain vascular health, and secondary outcomes include episodic memory and executive function. The trial aims to increase brain DHA synthesis from ALA and measure downstream biochemical and imaging changes associated with vascular and cognitive function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with amnestic mild cognitive impairment who carry at least one APOE4 allele, can give informed consent, are fluent in English or Spanish, and have a study partner available.
Not a fit: Patients with dementia or other major neurological diseases, recent stroke, active cancer treatment, allergy to flaxseed or corn oil, or who are already taking flaxseed/fish oil supplements may not benefit or be eligible.
Why it matters
Potential benefit: If successful, ALA supplementation could offer a safe, low-cost way to raise brain DHA levels and slow cognitive decline in older APOE4 carriers.
How similar studies have performed: Prior DHA supplementation trials showed limited cognitive benefits in APOE4 carriers, so using ALA to boost endogenous DHA synthesis is a novel and as-yet unproven approach in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Brunswick, New Jersey
- Rutgers - Institute for Health — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Michal Beeri, PHD — Rutgers University
- Study coordinator: Claudio Mendes, MS
- Email: alastudy@njms.rutgers.edu
- Phone: 8489328412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.