NCT06933095 · RECRUITING
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia
This trial is testing whether a specialized form of the omega-3 fat DHA — bound to a carrier molecule called lysophosphatidylcholine, or LPC-DHA — gets into the brain more effectively than the standard form of DHA found in most fish oil supplements. Participants take capsules for 24 weeks and then have blood and spinal fluid measured. This is a Phase NA study, meaning it is an exploratory comparison trial, not yet a proven or approved intervention.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-18