NCT06933095 Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
| NCT ID | NCT06933095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cincinnati |
| Condition | Eldery People |
| Study Type | INTERVENTIONAL |
| Enrollment | 153 participants |
| Start Date | 2024-09-15 |
| Primary Completion | 2029-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 153 participants in total. It began in 2024-09-15 with a primary completion date of 2029-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. men and women 55 to 82 years old; 2. presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR; 3. No contraindication to a lumbar puncture (LP) unless opting to not have the LP (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 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; 2. self-reported history of any psychotic disorder or bipolar disorder; 3. diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder; 4. allergy to shellfish or seafood; 5. current substance use causing physiological dependence or persisting change in functional capability; 6. concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications; 7. weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Contact & Investigator
Robert McNamara, PhD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT06933095 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 82 Years, studying Eldery People. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06933095 currently recruiting?
Yes, NCT06933095 is actively recruiting participants. Contact the research team at mcnamar@ucmail.uc.edu for enrollment information.
Where is the NCT06933095 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06933095 clinical trial?
NCT06933095 is sponsored by University of Cincinnati. The principal investigator is Robert McNamara, PhD at University of Cincinnati. The trial plans to enroll 153 participants.