Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 62
Maximum Age: 80
Healthy Volunteers: f
View:

• men and women 62 to 80 years old;

• presence of subjective cognitive decline using the SCD questionnaire, DEX and EMQ, education-adjusted MoCA score of \>23 \[106,107\]; and preservation of independence in functional abilities, as corroborated by an informant providing information on the mCDR \[108\];

• No contraindication to a lumbar puncture (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.

Locations
United States
Ohio
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
RECRUITING
Cincinnati
Contact Information
Primary
Robert McNamara, PhD
mcnamar@ucmail.uc.edu
513-558-8621
Backup
Robert Krikorian, PhD
KRIKORR@UCMAIL.UC.EDU
513-558-8621
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2029-09-15
Participants
Target number of participants: 153
Treatments
Placebo_comparator: Placebo (mixture of olive oil, corn oil, palm oil)
Placebo
Active_comparator: fish oil
Fish Oil
Experimental: LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified t
LPC-EPA+DHA (investigational agent) capsules containing omega-3 fatty acids EPA and DHA esterified to lysophosphatidylcholine (LPC-EPA+DHA)(Trade name: Lysoveta)
Related Therapeutic Areas
Sponsors
Leads: University of Cincinnati

This content was sourced from clinicaltrials.gov