Status:
RECRUITING
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
Lead Sponsor:
University of Cincinnati
Conditions:
Eldery People
Cognitive Decline
Eligibility:
All Genders
55-82 years
Phase:
NA
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 centra...
Eligibility Criteria
Inclusion
- men and women 55 to 82 years old;
- presence of subjective cognitive decline or mild cognitive decline using the SCD questionnaire, DEX, EMQ, MoCA; and mCDR;
- No contraindication to a lumbar puncture (LP) unless opting to not have the LP (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
- fluency in English;
- ability to comprehend and comply with the research protocol; and
- provision of written informed consent.
Exclusion
- 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;
- self-reported history of any psychotic disorder or bipolar disorder;
- diagnosis of atrial fibrillation, pancreatic, liver, kidney or hematological coagulation disorder;
- allergy to shellfish or seafood;
- current substance use causing physiological dependence or persisting change in functional capability;
- concomitant, regular use of medications that might affect primary outcome measures or adversely interact with the study product including anticoagulant medications;
- weekly fish consumption more than 1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2029
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06933095
Start Date
September 15 2024
End Date
September 15 2029
Last Update
December 18 2025
Active Locations (1)
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1
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219