Clinical trial

The Delivery of Essential Fatty Acids to the Brain

Name
HS-18-00291/00984
Description
Carrying the APOE ɛ4 allele is the strongest genetic risk factor for developing Alzheimer's disease. The goal of this project is to identify whether carrying the APOE ɛ4 allele is associated with reduced delivery of DHA to the brain. This information will help us identify the target population that could benefit from DHA supplementation to prevent cognitive decline.
Trial arms
Trial start
2018-09-01
Estimated PCD
2024-05-16
Trial end
2024-05-16
Status
Completed
Phase
Early phase I
Treatment
DHA
DHA supplementation
Arms:
DHA
Placebo
Placebo for DHA
Arms:
Placebo
Size
365
Primary endpoint
change in cerebrospinal fluid fatty acid levels after the intervention in 184 subjects
6 months
Eligibility criteria
Inclusion Criteria: * Age: ≥ 55 and ≤ 80 * At least one dementia risk factor (obesity, education years, hypertension, hyperlipidemia) * Mini-Mental State Examination (MMSE) ≥ 25 * Logical Memory II delayed recall score ≥ 6 and ≤ 18 . Exclusion Criteria: * Diagnosis of dementia as assessed by the investigator * Use of omega-3 preparations in the last 3 months * \> 200 mg/day of DHA consumption using a validated questionnaire * Use of donepezil, rivastigmine, galantamine and/or memantine * Alcohol or drug abuse * A concomitant serious disease such as active cancer treatment or HIV. * Participation in a clinical trial in the last 30 days * Use of anticoagulants such as Plavix or Coumadin or the newer generation blood thinners.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind and randomized placebo controlled', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 365, 'type': 'ACTUAL'}}
Updated at
2024-06-07

1 organization

1 product

1 drug

1 indication

Product
DHA