Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT06933095
Status
Recruiting
Apply to this trial

Conditions

  • Cognitive Decline
  • DHA CNS Delivery
  • Eldery People
  • Memory Decline

Eligibility Criteria

Sex
ALL
Age
55 Years - 82 Years
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Sep 15, 2024
Status verified
Dec 2025
Primary completion
Sep 15, 2029
Completion
Sep 15, 2029

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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)

Primary Outcome Measure

CSF Docosahexaenoic acid (DHA) levels [ Time Frame: From baseline through week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati, Department of Psychiatry and Behavioral NeuroscienceCincinnatiOhio45219
Karen Tugrul
[email protected]
513-558-6831
Dawn Skirpan
[email protected]
513-558-8621

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By research site
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience· Cincinnati, OH

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