Improving DHA delivery in older adults at risk for dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effects of two different forms of DHA supplementation, LPC-DHA and TAG-DHA, on cerebrospinal fluid and blood DHA levels in elderly adults showing early signs of cognitive decline. Participants will receive either LPC-DHA or TAG-DHA capsules for 24 weeks, and the study will measure changes in neurodegenerative and neurotrophic biomarkers. The hypothesis is that LPC-DHA will be more effective than TAG-DHA in enhancing DHA levels and improving cognitive health markers.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Robert McNamara, PhD — University of Cincinnati
• Study coordinator: Robert McNamara, PhD
• Email: mcnamar@ucmail.uc.edu
• Phone: 513-558-6831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.