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Prevention study for Cognitive Dysfunction
Official title ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
ClinicalTrials.gov ID: NCT07392723
What this study is testing
What is Alpha-Linolenic Acid (2.6 g/day)?
Alpha-Linolenic Acid (2.6 g/day) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cognitive dysfunction.
Also referred to as Flaxseed Oil, ALA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.