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Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Recruiting
62-80 years
All
Phase N/A

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Overview

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

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 details
    Eldery People
    Cognitive Decline
    Memory Decline
    DHA CNS Delivery

NCT06933095

University of Cincinnati

15 October 2025

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