20 Participants Needed

Alpha-Linolenic Acid for Cognitive Decline

CM
RW
Overseen ByRebecca West-Mortimer, PHD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Michal Schnaider Beeri, Ph.D.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MB

Michal Beeri, PHD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for older adults aged 60+ with mild memory problems (MCI) who carry the APOE4 gene, linked to Alzheimer's. Participants must speak English or Spanish and have someone to report on their daily functioning. They should be able to consent and follow the study plan.

Inclusion Criteria

I am 60 years old or older.
I am fluent in English or Spanish.
I have someone who can share details about my daily activities.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily supplementation of 2.6 grams of ALA or placebo for six months

24 weeks
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Alpha-Linolenic Acid

Trial Overview

The trial tests if taking alpha-linolenic acid (ALA), an Omega-3 fatty acid, can help maintain brain health in those at risk of Alzheimer's due to the APOE4 gene. It compares ALA against a placebo in a randomized, double-blind setup.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALA GroupExperimental Treatment1 Intervention
Group II: Placebo Control GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michal Schnaider Beeri, Ph.D.

Lead Sponsor