ALA Supplement for Cognitive Decline in Older Adults
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
Recruiting
Phase 2Interventional Study
Cognitive DysfunctionAlzheimer DiseaseBlood-Brain BarrierApolipoprotein E, Deficiency or Defect ofBrain AgingFatty Acids, Omega-3
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Michal Schnaider Beeri, Ph.D. · Other
Who this trial is looking for
This trial is looking for older adults with mild memory issues who carry the APOE4 gene. Participants will take a nutritional supplement and have regular check-ups to assess their cognitive function and brain health.
Are You a Good Fit for This Trial?
You may be able to join if
I am 60 years or older
I have mild memory problems that do not interfere with daily life
I carry at least one APOE4 gene allele
I can speak English or Spanish fluently
I have a study partner who can share about my daily activities
I am able to give informed consent and attend study visits
You may not be able to join if
I have been diagnosed with dementia or another serious brain disease
I have a history of stroke or major neurological condition
I have a short life expectancy due to a serious medical condition
I am currently undergoing active cancer treatment
I am allergic to flaxseed oil or corn oil
I currently use flaxseed, flax oil, or fish oil supplements more than once a week
I have conditions that prevent me from having an MRI
I have a history of prostate cancer or a high PSA level at screening
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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 frien…
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.
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