Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06933095

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

55 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

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)

Primary outcomes

  1. CSF Docosahexaenoic acid (DHA) levels

    Time frame: From baseline through week 24

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

Secondary outcomes

  1. Amyloid-β1-42 (Aβ42)

    Time frame: Baseline through week 24

    Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)

  2. Phospho-tau217 (p-tau217)

    Time frame: Baseline and Week 24

    Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)

  3. Brain-derived neurotrophic factor (BDNF)

    Time frame: Baseline and Week 24

    Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)

  4. Genotyping

    Time frame: Baseline

    APOE alleles (ε2, ε3, ε4) allele frequency

  5. California Verbal Learning Test

    Time frame: Baseline, Week 12, Week 24

    Objective assessment of episodic memory performance (Units on a scale) Scores range from 0 to 16 for individual learning trials, 0 to 80 for total words recalled across all trials, 0 to 16 for both short and long-delay free recall, and 0 to 16 for total hits. Higher scores indicate better performance on verbal memory

  6. Trail-Making Test, part B

    Time frame: Baseline, week 12, and week 24

    Objective measure of speed of processing/executive functioning (Units on a scale). Scores range from 0 to 300 seconds to complete the task. Lower scores indicate better performance on executive function.

  7. Geriatric Depression Scale

    Time frame: Screening, Baseline, week 12, and week 24

    Assessment of depression symptom severity (Units on a scale). The score range is from 0 to 15, with higher scores indicating more severe depression.

Other outcomes

  1. Blood glucose levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood glucose concentrations (mg/dL) as a measure of glucose regulation and insulin resistance.

  2. Blood insulin levels

    Time frame: Baseline, Week 12, week 24

    Fasting blood insulin concentrations (pmol/L) as a measure of glucose homeostasis and insulin effectiveness.

  3. Blood triglycerides levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood triglycerides concentrations (mg/dL)

  4. Blood cholesterol levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood cholesterol concentrations (mg/dL)

  5. Blood alanine transaminase (ALT) levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood alanine transaminase concentrations (U/L) as a measure of liver function

  6. Blood aspartate aminotransferase (AST) levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood aspartate aminotransferase concentrations (U/L) as a measure of liver function

  7. Blood C-reactive protein (CRP) levels

    Time frame: Baseline, week 12, and week 24

    Fasting blood C-reactive protein levels concentrations (mg/dL) as a measure of systemic inflammation

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Krikorian, PhD

CONTACT

[email protected]

513-558-6831

Robert McNamara, PhD

CONTACT

[email protected]

513-558-6831

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.