Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

NCT ID: NCT06933095

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2029-09-15

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.

Conditions

Eldery People; Cognitive Decline; Memory Decline; DHA CNS Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Placebo (mixture of olive oil, corn oil, palm oil)

Placebo

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

fish oil

Fish Oil

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

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)

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

LPC-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)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Robert McNamara

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert McNamara, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert McNamara, PhD

Role: CONTACT

Phone: 513-558-6831

Email: mcnamar@ucmail.uc.edu

Robert Krikorian, PhD

Role: CONTACT

Phone: 513-558-6831

Email: KRIKORR@UCMAIL.UC.EDU

Facility Contacts

Karen Tugrul

Role: primary

Dawn Skirpan

Role: backup

Other Identifiers

CNS DHA Delivery

Identifier Type: -

Identifier Source: org_study_id