NCT07392723RecruitingPhase 2
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 12 Jan 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Michal Schnaider Beeri, Ph.D.
- Diseases
- Alzheimer disease
- NCT number
- NCT07392723
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 12 Jan 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI contraindications, such as pacemakers, metallic implants, or severe claustrophobia.
- Use of experimental Alzheimer's treatments (e.g., amyloid monoclonal antibodies) unless on a stable regimen as confirmed by the treating physician.
Other illness
- 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 or past history of prostate cancer, regardless of remission status, OR a prostate-specific antigen (PSA) level \> 20 ng/mL at screening.
Other
- Current use of flaxseed, flax oil, or fish oil supplements more than once per week.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers - Institute for Health Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.