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
BASIC_SCIENCE
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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