Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Phase

N/A

Condition

Dementia

Mental Disability

Alzheimer's Disease

Treatment

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

Clinical Study ID

NCT06933095

CNS DHA Delivery

Ages 55-82
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

men and women 55 to 82 years old;
presence of subjective cognitive decline or mild cognitive decline using the SCDquestionnaire, 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;
ability to comprehend and comply with the research protocol; and
provision of written informed consent.

Exclusion

Exclusion Criteria:

diagnosis of dementia due to AD, Parkinson's disease, frontotemporal dementia,multi-infarct dementia, head trauma with loss of consciousness lasting more than 5minutes and resulting in persisting functional decline within the three years priorto enrollment, epilepsy, leukoencephalopathy, other neurological conditions thatwould 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 hematologicalcoagulation disorder;
allergy to shellfish or seafood;
current substance use causing physiological dependence or persisting change infunctional capability;
concomitant, regular use of medications that might affect primary outcome measuresor adversely interact with the study product including anticoagulant medications;
weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containingsupplements within 3 months prior to screening.

Study Design