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: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• 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]; CVLT cumulative acquisition score >1.5 SD below the age-adjusted mean, 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 diabetes, 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
Amyloid-β1-42 (Aβ42)	Baseline through week 24	Baseline-Endpoint change in blood and CSF amyloid-β1-42 concentrations (ng/ml)
Phospho-tau217 (p-tau217)	Baseline and Week 24	Baseline-Endpoint change in blood and CSF p-tau217 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
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.
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