NCT07392723 ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
| NCT ID | NCT07392723 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michal Schnaider Beeri, Ph.D. |
| Condition | Cognitive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-12 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-01-12 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Michal Beeri, PHD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT07392723 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07392723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07392723 currently recruiting?
Yes, NCT07392723 is actively recruiting participants. Contact the research team at alastudy@njms.rutgers.edu for enrollment information.
Where is the NCT07392723 trial being conducted?
This trial is being conducted at New Brunswick, United States.
Who is sponsoring the NCT07392723 clinical trial?
NCT07392723 is sponsored by Michal Schnaider Beeri, Ph.D.. The principal investigator is Michal Beeri, PHD at Rutgers University. The trial plans to enroll 20 participants.