Recruiting

Phase 2

Alpha-Linolenic AcidALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults

Sponsor:

Michal Schnaider Beeri, Ph.D.

Code:

NCT07392723

Conditions

Cognitive Dysfunction

Alzheimer Disease

Blood-Brain Barrier

Apolipoprotein E, Deficiency or Defect of

Brain Aging

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Alpha-Linolenic Acid (2.6 g/day)

Placebo Control Group

Study Details

Brief 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.

Conditions

Cognitive Dysfunction

Alzheimer Disease

Blood-Brain Barrier

Apolipoprotein E, Deficiency or Defect of

Brain Aging

Study ID

NCT07392723

Start date

Jan 12, 2025

Status verified date

Jan, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Alpha-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.

Placebo 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.

Primary outcome measure

Change in global cognitive (score) function [ Time Frame: Baseline and 6 months ]
Change in Blood-Brain Barrier Integrity - Permeability of the BBB [ Time Frame: Baseline and 6 months ]
Levels of blood biomarkers of BBB Integrity [ Time Frame: baseline and 6 months ]

Central Contacts and Locations

Central contacts

Claudio Mendes, MS

8489328412 alastudy@njms.rutgers.edu

Rebecca West-Mortimer, PHD

8489328415 alastudy@njms.rutgers.edu

Locations

Rutgers - Institute for Health

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Claudio Mendes

claudio.mendes@rutgers.edu

More Information

Sponsor

Michal Schnaider Beeri, Ph.D.

Last update posted

Feb 6, 2026

Last verified

Jan, 2026

Keywords

Alpha-Linolenic Acid
Flaxseed Oil
Apolipoprotein E4
Nutritional Intervention
APOE4 Dysfunction
Cognitive Function
Brain MRI
Blood Biomarkers
Vascular Integrity
Neurodegeneration
Aging Brain
Memory Loss Prevention
AD Prevention Trial
Alzheimer's Disease
Cognitive decline prevention
Blood-brain barrier
Dementia prevention
Older adults
Biomarkers
Magnetic resonance imaging (MRI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michal Schnaider Beeri, Ph.D. on 2026-02-06.