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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
153
apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States
RECRUITINGCSF Docosahexaenoic acid (DHA) levels
Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).
Time frame: From baseline through week 24
Amyloid-β1-42 (Aβ42)
Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Time frame: Baseline through week 24
Phospho-tau217 (p-tau217)
Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)
Time frame: Baseline and Week 24
Brain-derived neurotrophic factor (BDNF)
Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)
Time frame: Baseline and Week 24
Genotyping
APOE alleles (ε2, ε3, ε4) allele frequency
Time frame: Baseline
California Verbal Learning Test
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, Week 24
Trail-Making Test, part B
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: Baseline, week 12, and week 24
Geriatric Depression Scale
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: Screening, Baseline, week 12, and week 24
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