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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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
United States
New Jersey
Rutgers - Institute for Health
RECRUITING
New Brunswick
Contact Information
Primary
Claudio Mendes, MS
alastudy@njms.rutgers.edu
8489328412
Backup
Rebecca West-Mortimer, PHD
alastudy@njms.rutgers.edu
8489328415
Time Frame
Start Date: 2025-01-12
Estimated Completion Date: 2027-10
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Michal Schnaider Beeri, Ph.D.

This content was sourced from clinicaltrials.gov

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