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

Recruiting now · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT07392723

Run by

Michal Schnaider Beeri, Ph.D.

People needed

20

Starts

2025-01-12

Expected to finish

2027-10-01

Last updated by the study team

2026-02-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Rutgers - Institute for Health — New Brunswick, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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