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Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Site contact updatedv7
  3. Eligibility criteria expanded, about 16 wordsv6 See this version in full on ClinicalTrials.gov ↗
  4. Eligibility criteria shortened, about 10 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Eligibility criteria expanded, about 1 wordv4 See this version in full on ClinicalTrials.gov ↗
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  1. Site contact updatedv3
  2. Trial status: Active, Not Recruiting to Recruiting Secondary endpoints: details revised at 3 of 7 entries · Site details revisedv2 Show 2 more changesShow less
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06933095
Lead Sponsor University of Cincinnati
Conditions Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov