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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (mixture of olive oil, corn oil, palm oil) | Placebo Comparator | Placebo |
|
| fish oil | Active Comparator | Fish Oil |
|
| LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t | Experimental | LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| CSF Docosahexaenoic acid (DHA) levels | Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g). | From baseline through week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Amyloid-β1-42 (Aβ42) | Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml) | Baseline through week 24 |
| Phospho-tau217 (p-tau217) | Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose levels | Fasting blood glucose concentrations (mg/dL) as a measure of glucose regulation and insulin resistance. | Baseline, week 12, and week 24 |
| Blood insulin levels | Fasting blood insulin concentrations (pmol/L) as a measure of glucose homeostasis and insulin effectiveness. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert McNamara, PhD | Contact | 513-558-6831 | mcnamar@ucmail.uc.edu | |
| Robert Krikorian, PhD | Contact | 513-558-6831 | KRIKORR@UCMAIL.UC.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Robert McNamara, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience | Recruiting | Cincinnati | Ohio | 45219 | United States |
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|
| Baseline and Week 24 |
| Brain-derived neurotrophic factor (BDNF) | Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml) | Baseline and Week 24 |
| Genotyping | APOE alleles (ε2, ε3, ε4) allele frequency | 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 | 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. | 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. | Screening, Baseline, week 12, and week 24 |
| Baseline, Week 12, week 24 |
| Blood triglycerides levels | Fasting blood triglycerides concentrations (mg/dL) | Baseline, week 12, and week 24 |
| Blood cholesterol levels | Fasting blood cholesterol concentrations (mg/dL) | Baseline, week 12, and week 24 |
| Blood alanine transaminase (ALT) levels | Fasting blood alanine transaminase concentrations (U/L) as a measure of liver function | Baseline, week 12, and week 24 |
| Blood aspartate aminotransferase (AST) levels | Fasting blood aspartate aminotransferase concentrations (U/L) as a measure of liver function | Baseline, week 12, and week 24 |
| Blood C-reactive protein (CRP) levels | Fasting blood C-reactive protein levels concentrations (mg/dL) as a measure of systemic inflammation | Baseline, week 12, and week 24 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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