Cognitive Decline, DHA CNS Delivery, Eldery People, Memory Decline
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
apsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
1. men and women 55 to 82 years old; 2. presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR; 3. No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.); 4. fluency in English; 5. ability to comprehend and comply with the research protocol; and 6. provision of written informed consent.
Exclusion criteria
1. diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, head trauma with loss of consciousness lasting more than 5 minutes and resulting in persisting functional decline within the three years prior to enrollment, epilepsy, leukoencephalopathy, other neurological conditions that would interfere the study objectives, mMIST \<8 or MoCA-MI score \<7; 2. self-reported history of any psychotic disorder or bipolar disorder; 3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder; 4. allergy to shellfish or seafood; 5. current substance use causing physiological dependence or persisting change in functional capability; 6. concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications; 7. weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF Docosahexaenoic acid (DHA) levels | From baseline through week 24 | Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amyloid-β1-42 (Aβ42) | Baseline through week 24 | Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml) |
| Phospho-tau217 (p-tau217) | Baseline and Week 24 | Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml) |
| Brain-derived neurotrophic factor (BDNF) | Baseline and Week 24 | Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml) |
| Genotyping | Baseline | APOE alleles (ε2, ε3, ε4) allele frequency |
| California Verbal Learning Test | 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 |
| Trail-Making Test, part B | 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. |
| Geriatric Depression Scale | 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. |
Countries
United States
Contacts
CONTACTRobert McNamara, PhD
CONTACTRobert Krikorian, PhD
PRINCIPAL_INVESTIGATORRobert McNamara, PhD
University of Cincinnati
Outcome results
None listed