ALA-enriched nutrition to prevent cognitive decline in older adults with APOE4

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.