Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

NCT06933095 | Recruiting DMC

• 1 other identifier: CNS DHA Delivery
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• CSF Docosahexaenoic acid (DHA) levels

  Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).

  From baseline through week 24

Secondary Outcomes (7)

• Amyloid-β1-42 (Aβ42)

  Baseline through week 24

• Phospho-tau217 (p-tau217)

  Baseline and Week 24

• Brain-derived neurotrophic factor (BDNF)

  Baseline and Week 24

• Genotyping

  Baseline

• California Verbal Learning Test

  Baseline, Week 12, Week 24

Other Outcomes (7)

• Blood glucose levels

  Baseline, week 12, and week 24

• Blood insulin levels

  Baseline, Week 12, week 24

• Blood triglycerides levels

  Baseline, week 12, and week 24

Study Arms (3)

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

PLACEBO COMPARATOR

Placebo

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

fish oil

ACTIVE COMPARATOR

Fish Oil

Dietary Supplement: LPC-EPA+DHA capsules 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

EXPERIMENTAL

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

Dietary Supplement: LPC-EPA+DHA capsules 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) 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; Placebo (mixture of olive oil, corn oil, palm oil); fish oil

Eligibility Criteria

• Age: 55 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ability to comprehend and comply with the research protocol; and
• provision of written informed consent.

You may not qualify if:

• 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;
• current substance use causing physiological dependence or persisting change in functional capability;
• concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications;
• weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Robert McNamara, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert McNamara, PhD

CONTACT

513-558-6831; mcnamar@ucmail.uc.edu

Robert Krikorian, PhD

CONTACT

513-558-6831; KRIKORR@UCMAIL.UC.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: April 18, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2029
• Study Completion (Estimated): September 15, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)