RecruitingPhase 2NCT07392723

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

Sponsor

Michal Schnaider Beeri, Ph.D.

Enrollment

20 participants

Start Date

Jan 12, 2025

Study Type

INTERVENTIONAL

Conditions

Cognitive Dysfunction Alzheimer Disease Fatty Acids, Omega-3 Blood-Brain Barrier Apolipoprotein E, Deficiency or Defect of Brain Aging

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a dietary supplement rich in alpha-linolenic acid (ALA) — an omega-3 fatty acid found in plant oils — can slow cognitive decline in older adults with mild memory problems who carry the APOE4 gene, a genetic risk factor for Alzheimer's disease. **You may be eligible if...** - You are 60 years or older - You have mild cognitive impairment (MCI) — noticeable memory problems that don't yet prevent you from managing daily life - You carry at least one copy of the APOE4 gene (confirmed by a blood test) - You speak English or Spanish fluently - You have a family member or close friend who can provide information about how you function day-to-day **You may NOT be eligible if...** - You have been diagnosed with dementia or Alzheimer's disease - You have a history of stroke, brain injury, or other major neurological condition - You are already taking omega-3 supplements or eating a very high ALA diet - You have a serious or terminal medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlpha-Linolenic Acid (2.6 g/day)

Participants in this group will take flaxseed oil that contains 2.6 grams of alpha-linolenic acid (ALA) each day for six months. The oil will be provided in 5 mL prefilled oral syringes prepared by the Rutgers Clinical Research Pharmacy. Participants will take one syringe daily in the morning with food. They may mix the oil with cold foods such as yogurt or applesauce but should not heat it. The ALA supplement is intended to improve cognitive and brain health by enhancing the body's natural production of DHA that supports blood-brain barrier integrity and brain function.

DIETARY_SUPPLEMENTPlacebo Control Group

Participants in this group will take corn oil that does not contain ALA. The oil will be provided in the same 5 mL prefilled oral syringes as the active supplement and will look, taste, and smell similar to the ALA oil. Participants will take one syringe daily in the morning with food for six months. The placebo is used to compare effects against the ALA supplement and to maintain blinding for both participants and study staff.

Locations(1)

Rutgers - Institute for Health

New Brunswick, New Jersey, United States

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NCT07392723

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