Actively Recruiting
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Led by University of Cincinnati · Updated on 2025-12-18
153
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 including those with mild cognitive impairment (MCI). 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
Official Title
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 55 to 82 years
- Experiencing subjective or mild cognitive decline confirmed by questionnaires and tests (SCD questionnaire, DEX, EMQ, MoCA, mCDR)
- No contraindications to lumbar puncture unless opting out (e.g., thrombocytopenia, coagulopathy, use of anticoagulants)
- Fluent in English
- Able to understand and comply with study procedures
- Provide written informed consent
You will not qualify if you...
- Diagnosis of dementia due to Alzheimer's, Parkinson's, frontotemporal dementia, multi-infarct dementia, recent head trauma with lasting decline, epilepsy, leukoencephalopathy, or other interfering neurological conditions
- Scores below thresholds on mMIST (<8) or MoCA-MI (<7)
- History of psychotic or bipolar disorder
- Diagnosis of atrial fibrillation or certain coagulation disorders
- Allergy to shellfish or seafood
- Current substance use causing dependence or functional changes
- Regular use of medications affecting outcomes or interacting with study product including anticoagulants
- Weekly fish intake over one 3 oz serving or DHA supplement use within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
R
Robert McNamara, PhD
CONTACT
R
Robert Krikorian, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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