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 trial explores whether alpha-linolenic acid (ALA), found in flaxseed oil, can improve brain health and memory in older adults with mild memory problems who carry the APOE4 gene, linked to Alzheimer's risk. Researchers aim to determine if ALA can increase DHA production, a brain-friendly fat, and enhance brain health without the side effects of current Alzheimer's drugs. Participants will receive either ALA or a placebo (a look-alike treatment with no active ingredient) daily for six months. Suitable candidates have slight memory issues that do not disrupt daily life and possess at least one APOE4 gene. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use flaxseed, flax oil, or fish oil supplements more than once a week, and you should not be on experimental Alzheimer's treatments unless your regimen is stable.

Is there any evidence suggesting that alpha-linolenic acid is likely to be safe for humans?

Research has shown that alpha-linolenic acid (ALA) affects brain health. Studies have found that ALA can improve memory, including learning and short-term memory, particularly in older adults. No serious side effects have been reported, suggesting ALA is generally safe.

One study suggested that ALA might protect the brain by supporting certain functions. However, not all studies agree on its effectiveness in preventing memory problems. Despite this, ALA has not been linked to major safety issues.

Since this trial is in an early stage, researchers are closely monitoring ALA's safety, but past research provides some confidence about its safety. This information may help prospective participants feel more informed about the treatment's safety.12345

Why do researchers think this study treatment might be promising?

Most treatments for cognitive decline aim to manage symptoms using medications like cholinesterase inhibitors or memantine. But alpha-linolenic acid (ALA) offers a different approach. ALA is a type of omega-3 fatty acid, derived from flaxseed oil, that may support brain health by reducing inflammation and promoting cell membrane integrity. Unlike traditional medications that primarily focus on chemical imbalances, ALA works by providing essential nutrients that could enhance brain function naturally. Researchers are excited about ALA's potential as a dietary supplement that might offer a safer, more natural alternative with fewer side effects.

What evidence suggests that alpha-linolenic acid might be an effective treatment for cognitive decline?

Research has shown that alpha-linolenic acid (ALA), which participants in this trial may receive, can improve brain function. Studies have found that ALA boosts learning and memory in older adults, potentially preventing memory problems. Other research suggests that ALA supports brain health by strengthening the brain's protective barrier, which keeps harmful substances out, and by enhancing overall brain function. ALA likely works by increasing levels of docosahexaenoic acid (DHA), an important nutrient for the brain. These findings suggest ALA could be a helpful treatment for memory and thinking issues, especially for those at risk for Alzheimer's.12678

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

Citations

How Alpha Linolenic Acid May Sustain Blood–Brain Barrier ...

Alpha linolenic acid (ALA), the precursor of the majoritarian brain component docosahexaenoic acid (DHA), emerges as a potential novel brain savior.

Important roles of linoleic acid and α-linolenic ...

Other current studies have reported that ALA administration leads to the improvement in cognitive impairment ... cognitive decline in AD ...

The Role of Alpha-Linolenic Acid and Other ...

Indeed, ALA has been shown to improve learning, and semantic, spatial, and short-term memory in the elderly, thus preventing cognitive decline.

Alpha-Linolenic Acid Ameliorates Cognitive Impairment ... - PMC

ALA treatment suppressed adipose accumulation in adipocytes, improved cognitive ability and colon integrity, and alleviated liver damage.

Effects of N-3 Polyunsaturated Fatty Acids on Dementia | Yanai

This study suggested that DHA-enriched meals protect against age-related cognitive decline, and also improve apathy and caregiver burden for the oldest-elderly ...

Alpha-Linolenic Acid from Perilla frutescens var. japonica Oil ...

Alpha-Linolenic Acid from Perilla frutescens var. japonica Oil Protects Aβ-Induced Cognitive Impairment through Regulation of APP Processing and Aβ Degradation.

Current evidence for the clinical use of long-chain ...

The available evidence does not prove that n-3 LC-PUFA supplements can protect against cognitive decline or dementia. RCT studies in Alzheimer's patients have ...

Cognitive and Mood Effect of Alpha-Lipoic Acid ... - PMC - NIH

Conclusions: Despite several limitations, our study found no evidence of positive effects on cognition and mood after ALA administration in ...