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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomized to either daily supplementation of 2.6 grams of ALA or a placebo (corn oil) for six months."
  • "Secondary outcomes will be episodic memory and executive functions. 2) Cerebral vasculature: The primary neurobiological outcome will be BBB integrity, assessed via MRI."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether alpha-linolenic acid (ALA), a nutrient supplement, helps memory, thinking, brain blood vessels, and the barrier that protects the brain. It is for adults age 60 or older who have mild memory problems and carry the APOE4 gene variant. The study compares ALA with a placebo, a supplement with no active study ingredient.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 60 or older.
  • Have mild cognitive impairment (MCI): memory problems that do not interfere with daily life.
  • Have at least one copy of the APOE4 gene variant, confirmed by a blood test.
  • Be fluent in English or Spanish.
  • Have a family member or friend who can share information about your daily activities.
  • Be able to agree to join the study and follow its visit and testing requirements.

Who can't join

  • Have dementia or another brain disease that greatly affects thinking or memory, or a history of stroke or another major nervous system condition.
  • Have a serious illness that is expected to shorten your life.
  • Be getting cancer treatment that could interfere with taking part.
  • Have an allergy or sensitivity to flaxseed oil or corn oil.
  • Take flaxseed, flax oil, or fish oil supplements more than once a week.
  • Be unable to have an MRI scan because of a pacemaker, metal implant, or severe fear of enclosed spaces.
  • Have prostate cancer now or in the past, even if it is no longer active, or have a PSA (prostate-specific antigen) blood test level above 20 ng/mL at screening.
  • Use experimental Alzheimer's treatments unless your treating doctor confirms that your treatment plan is stable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NJ