Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-82
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
men and women 55 to 82 years old;
presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;
No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
fluency in English;
Disqualifiers
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;
self-reported history of any psychotic disorder or bipolar disorder;
diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
allergy to shellfish or seafood;
Trial design
Design model
Parallel
Treatments tested in this trial
LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
Dietary supplementapsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
Treatment groups
153 Participants
are divided into 3 treatment groupsGroup A: Placebo (mixture of olive oil, corn oil, palm oil)Placebo comparator 1 intervention
Group B: fish oilActive comparator 1 intervention
Group C: LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified tExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CSF Docosahexaenoic acid (DHA) levels
Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).
Time frame
From baseline through week 24Secondary outcomes
1
Amyloid-β1-42 (Aβ42)
Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Time frame
Baseline through week 242
Phospho-tau217 (p-tau217)
Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)
Time frame
Baseline and Week 243
Brain-derived neurotrophic factor (BDNF)
Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)
Time frame
Baseline and Week 244
Genotyping
APOE alleles (ε2, ε3, ε4) allele frequency
Time frame
BaselineOther outcomes
1
Blood glucose levels
Fasting blood glucose concentrations (mg/dL) as a measure of glucose regulation and insulin resistance.
Time frame
Baseline, week 12, and week 242
Blood insulin levels
Fasting blood insulin concentrations (pmol/L) as a measure of glucose homeostasis and insulin effectiveness.
Time frame
Baseline, Week 12, week 243
Blood triglycerides levels
Fasting blood triglycerides concentrations (mg/dL)
Time frame
Baseline, week 12, and week 244
Blood cholesterol levels
Fasting blood cholesterol concentrations (mg/dL)
Time frame
Baseline, week 12, and week 24Sponsors and contacts
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Source ClinicalTrials.gov