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Search / Trial NCT06933095

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

Launched by UNIVERSITY OF CINCINNATI · Apr 10, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how two different forms of DHA (a type of omega-3 fatty acid) affect brain health in older adults who are experiencing early signs of memory decline. The trial will last for 24 weeks and will compare the effects of LPC-DHA and TAG-DHA on levels of DHA in the blood and brain, as well as other markers related to brain health. Researchers believe that LPC-DHA may be more effective than TAG-DHA in improving these levels and overall brain function.

To participate in this study, individuals should be between 62 and 80 years old, showing early signs of cognitive decline but still able to live independently. They should not have any serious neurological conditions or certain health issues that could interfere with the study. Participants will need to provide consent and may have some tests done to ensure they qualify. Throughout the trial, participants can expect regular check-ins and assessments to monitor their progress. This study aims to find better ways to support brain health as we age.

Gender

ALL

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 \>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 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.

About University Of Cincinnati

The University of Cincinnati is a leading research institution dedicated to advancing healthcare through innovative clinical trials and studies. With a robust focus on translational research, the university fosters a collaborative environment that integrates cutting-edge science with clinical practice. Its diverse team of experts, equipped with state-of-the-art facilities, is committed to exploring new therapeutic interventions aimed at improving patient outcomes. The University of Cincinnati actively engages in partnerships with industry and academia to drive forward-thinking solutions in medicine, ensuring that research findings are effectively translated into real-world applications.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Robert McNamara, PhD

Principal Investigator

University of Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported