Improving DHA delivery in older adults at risk for dementia

Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

This study is testing whether two different types of DHA supplements can improve brain health in older adults who are showing early signs of memory problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 55 Years to 82 Years
• Sex: All
• Sponsor: University of Cincinnati (other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT06933095 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 62 to 80 who exhibit early signs of cognitive decline but do not have a diagnosis of significant neurological conditions.

Not a fit: Patients with diagnosed cognitive impairments such as Alzheimer's disease or other significant neurological disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive health and potentially delay the onset of dementia in at-risk elderly individuals.

How similar studies have performed: While there is existing evidence supporting the benefits of DHA supplementation, this specific comparison of LPC-DHA and TAG-DHA is a novel approach.

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.

Where this trial is running

Cincinnati, Ohio

• 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

Conditions: Eldery People, Cognitive Decline, Memory Decline, DHA CNS Delivery