University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219, United States
Location status: Recruiting
Location contact
Dawn Skirpan
CONTACT
Karen Tugrul
CONTACT
NCT Number: NCT06933095
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.
Interested in participating?
Request Info55 year–82 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45219, United States
Location status: Recruiting
Dawn Skirpan
CONTACT
Karen Tugrul
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
Time frame: From baseline through week 24
Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).
Time frame: Baseline through week 24
Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Time frame: Baseline and Week 24
Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)
Time frame: Baseline and Week 24
Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)
Time frame: Baseline
APOE alleles (ε2, ε3, ε4) allele frequency
Time frame: Baseline, Week 12, Week 24
Objective assessment of episodic memory performance (Units on a scale) Scores range from 0 to 16 for individual learning trials, 0 to 80 for total words recalled across all trials, 0 to 16 for both short and long-delay free recall, and 0 to 16 for total hits. Higher scores indicate better performance on verbal memory
Time frame: Baseline, week 12, and week 24
Objective measure of speed of processing/executive functioning (Units on a scale). Scores range from 0 to 300 seconds to complete the task. Lower scores indicate better performance on executive function.
Time frame: Screening, Baseline, week 12, and week 24
Assessment of depression symptom severity (Units on a scale). The score range is from 0 to 15, with higher scores indicating more severe depression.
Time frame: Baseline, week 12, and week 24
Fasting blood glucose concentrations (mg/dL) as a measure of glucose regulation and insulin resistance.
Time frame: Baseline, Week 12, week 24
Fasting blood insulin concentrations (pmol/L) as a measure of glucose homeostasis and insulin effectiveness.
Time frame: Baseline, week 12, and week 24
Fasting blood triglycerides concentrations (mg/dL)
Time frame: Baseline, week 12, and week 24
Fasting blood cholesterol concentrations (mg/dL)
Time frame: Baseline, week 12, and week 24
Fasting blood alanine transaminase concentrations (U/L) as a measure of liver function
Time frame: Baseline, week 12, and week 24
Fasting blood aspartate aminotransferase concentrations (U/L) as a measure of liver function
Time frame: Baseline, week 12, and week 24
Fasting blood C-reactive protein levels concentrations (mg/dL) as a measure of systemic inflammation
Contact information is provided by the study sponsor or research team.
Robert Krikorian, PhD
CONTACT
Robert McNamara, PhD
CONTACT
University of Cincinnati
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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