Clinical trial NCT06933095: Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Official title: Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eldery People
Cognitive Decline
Memory Decline
DHA CNS Delivery
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 153
Sex: ALL
Minimum age (years): 62
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 \&gt;23 \[106,107\]; CVLT cumulative acquisition score \&gt;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 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 \&gt;1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.

Primary outcomes:
measure: CSF Docosahexaenoic acid (DHA) levels
timeFrame: From baseline through week 24
Secondary outcomes:
measure: Amyloid-β1-42 (Aβ42)
timeFrame: Baseline through week 24
measure: Phospho-tau217 (p-tau217)
timeFrame: Baseline and Week 24
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: Baseline and Week 24
measure: Genotyping
timeFrame: Baseline
measure: California Verbal Learning Test
timeFrame: Baseline, Week 12, Week 24
measure: Trail-Making Test, part B
timeFrame: Baseline, week 12, and week 24
measure: Geriatric Depression Scale
timeFrame: Screening, Baseline, week 12, and week 24
Other outcomes:
measure: Blood glucose levels
timeFrame: Baseline, week 12, and week 24
measure: Blood insulin levels
timeFrame: Baseline, Week 12, week 24
measure: Blood triglycerides levels
timeFrame: Baseline, week 12, and week 24
measure: Blood cholesterol levels
timeFrame: Baseline, week 12, and week 24
measure: Blood alanine transaminase (ALT) levels
timeFrame: Baseline, week 12, and week 24
measure: Blood aspartate aminotransferase (AST) levels
timeFrame: Baseline, week 12, and week 24
measure: Blood C-reactive protein (CRP) levels
timeFrame: Baseline, week 12, and week 24
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert McNamara, PhD
role: PRINCIPAL_INVESTIGATOR
References: