NCT03613844CompletedPhase 2
DHA Brain Delivery Trial
The Delivery of Essential Fatty Acids to the Brain
Source: ClinicalTrials.gov · Last updated 7 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 365 (actual)
- First submitted
- 11 Jul 2018
- Start date
- 1 Sept 2018
- Primary completion date
- 16 May 2024
- Lead sponsor
- University of Southern California
- Diseases
- Alzheimer disease
- NCT number
- NCT03613844
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 365
- From 1 Sept 2018 to the primary completion date, 16 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse
- A concomitant serious disease such as active cancer treatment or HIV.
Other illness
- Diagnosis of dementia as assessed by the investigator
Other
- 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
- Participation in a clinical trial in the last 30 days
- Use of anticoagulants such as Plavix or Coumadin or the newer generation blood thinners.
Who the study is looking for
- 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 .
Age in the registry: 55 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| USC Keck School of Medicine Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.