ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Michal Schnaider Beeri, Ph.D.
Study ID
NCT07392723
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Alpha-Linolenic Acid (2.6 g/day) — DRUG
    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.
  • Placebo Control Group — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Jan 12, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALA Group
    Participants receive flaxseed oil in 5 mL oral syringes containing 2.6g of ALA, taken daily for six months.
  • Placebo Comparator: Placebo Control Group
    Participants receive corn oil without ALA (iso-caloric placebo) in 5 mL oral syringes that are identical in appearance to those containing ALA, taken daily for six months.

Primary Outcome Measure

Change in global cognitive (score) function [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers - Institute for HealthNew BrunswickNew Jersey08901
Claudio Mendes
[email protected]

Find similar trials in New Brunswick, NJ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Rutgers - Institute for Health· New Brunswick, NJ

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