NCT07392723 · Phase 2 · RECRUITING
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
This trial tests whether a daily dose of alpha-linolenic acid (ALA), a plant-based omega-3 found in flaxseed oil, affects memory and thinking, and the health of the blood-brain barrier and brain blood vessels. Participants get ALA or a placebo. It is a small Phase 2 pilot, testing early signals and safety, not yet proven or approved.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-06