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Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Sponsor: University of Cincinnati • ClinicalTrials.gov ID: NCT06933095

Registry updated: 2026-08-19

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Description

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.

Interventions

LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) (Dietary supplement)
apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Eligibility criteria

Inclusion Criteria: 1. men and women 55 to 82 years old; 2. presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR; 3. No contraindication to a lumbar puncture (LP) unless opting to not have the LP (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: 1. diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST \<8 or MoCA-MI score \<7; 2. self-reported history of any psychotic disorder or bipolar disorder; 3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder; 4. allergy to shellfish or seafood; 5. current substance use causing physiological dependence or persisting change in functional capability; 6. concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications; 7. weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Conditions

Eldery People Cognitive Decline Memory Decline DHA CNS Delivery

Locations

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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