Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Purpose
The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood DHA levels, as well as biomarkers of central neurodegenerative and neurotrophic activity, in elderly adults experiencing early signs of cognitive/memory decline. Extant evidence supports our overarching hypothesis that LPC-DHA supplementation will be more effective than TAG-DHA for increasing central (CSF) DHA levels and improving biomarker profiles in elderly adults. To assess this hypothesis, the following aims are proposed: SPECIFIC AIM 1: To compare the effects of LPC-DHA and TAG-DHA supplementation on peripheral and CSF DHA levels in elderly adults experiencing early signs of cognitive/memory decline. SPECIFIC AIM 2: To compare the effects of LPC-DHA and TAG-DHA supplementation on neurotrophic and neurodegenerative biomarkers. Secondary Aim: To investigate whether changes in CSF DHA levels correlate with changes in objective measures of executive functioning and episodic memory performance.
Conditions
- Eldery People
- Cognitive Decline
- Memory Decline
- DHA CNS Delivery
Eligibility
- Eligible Ages
- Between 62 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- men and women 62 to 80 years old; 2. presence of subjective cognitive decline using the SCD questionnaire, DEX and EMQ, education-adjusted MoCA score of >23 [106,107]; CVLT cumulative acquisition score >1.5 SD below the age-adjusted mean, and preservation of independence in functional abilities, as corroborated by an informant providing information on the mCDR [108]; 3. No contraindication to a lumbar puncture (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.); 4. fluency in English; 5. ability to comprehend and comply with the research protocol; and 6. provision of written informed consent.
Exclusion Criteria
- diagnosis of MCI, AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, significant head trauma, epilepsy, leukoencephalopathy, or other neurological condition; 2. self-reported emotional disorder such as severe depression or other psychiatric condition causing a persisting decline in functional capability; 3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder; 4. allergy to shellfish or seafood; 5. current or past substance use causing physiological dependence or persisting change in functional capability; 6. concomitant, regular use of medications that might affect outcome measures or adversely interact with the study product including anticoagulant medications; 7. weekly fish consumption >1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo (mixture of olive oil, corn oil, palm oil) |
Placebo |
|
|
Active Comparator fish oil |
Fish Oil |
|
|
Experimental LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t |
LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
|
Recruiting Locations
Cincinnati, Ohio 45219
More Details
- NCT ID
- NCT06933095
- Status
- Recruiting
- Sponsor
- University of Cincinnati