Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Not Applicable

Recruiting

• Conditions: Eldery People; Cognitive Decline; Memory Decline; DHA CNS Delivery

• Registration Number: NCT06933095
• Lead Sponsor: University of Cincinnati

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-15
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Primary Completion: 2029-09-15
• Study Completion: 2029-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. men and women 62 to 80 years old;
2. 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];
3. No contraindication to a lumbar puncture (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 MCI, AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, significant head trauma, epilepsy, leukoencephalopathy, or other neurological condition;
2. self-reported emotional disorder such as severe depression or other psychiatric condition causing a persisting decline in functional capability;
3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
4. allergy to shellfish or seafood;
5. current or past substance use causing physiological dependence or persisting change in functional capability;
6. concomitant, regular use of medications that might affect outcome measures or adversely interact with the study product including anticoagulant medications;
7. weekly fish consumption >1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CSF Docosahexaenoic acid (DHA) levels	From baseline through week 24	Baseline-Endpoint change in CSF docosahexaenoic acid (DHA) composition (g/100 g).

Secondary Outcome Measures

Name	Time	Method
Phospho-tau217 (p-tau217)	Baseline and Week 24	Baseline-Endpoint change in blood and CSF p-tau217 concentrations (ng/ml)
Trail-Making Test, part B	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.
Amyloid-β1-42 (Aβ42)	Baseline through week 24	Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Brain-derived neurotrophic factor (BDNF)	Baseline and Week 24	Baseline-Endpoint change in blood and CSF BDNF concentrations (ng/ml)
Genotyping	Baseline	APOE alleles (ε2, ε3, ε4) allele frequency
California Verbal Learning Test	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
Geriatric Depression Scale	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.

Trial Locations

Locations (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience; 🇺🇸 Cincinnati, Ohio, United States