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Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

RecruitingNA

Sponsor: University of Cincinnati

Conditions: Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery

Interventions: LPC-EPA+DHA capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)

Countries: United States

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 overview

Sex: ALL

Age: 55 Years to 82 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Cincinnati, Ohio, United States