NCT05592678 · RECRUITING
δ in Dementia Clinical Trials
This trial is testing whether a new mathematical measure called delta (δ) can better predict and track how well donepezil — a standard, already-approved Alzheimer's medication — works in people with cognitive impairment or MCI. Researchers want to know if blood proteins called adipokines can help identify who will respond to the drug. This is a methods-focused study, not a new treatment — it is refining how future trials are designed and measured.
You may qualify if
- Ambulatory outpatient volunteers with competent informants. Competent informants are cognitively normal individual(s) who interacts with the person on a regular (at least 5 or more hours/week) basis and in the opinion of the PI can provide adequate collateral information on the participant's memory and cognitive status.
- Aged 65-100 years
- Clinical diagnosis of AD, or MCI.
- Capacity to give informed consent. If a patient is found to clinically decline during the course of the study and no longer able to provide consent, continued participation will be evaluated by the PI on a case-by-case basis.
- GDS score (15 item) ≤ 8
- No significant visual or hearing impairments
- A standardized dECog score between 1.5 and 3.5 relative to ADNI's cohort.
You're excluded if
- A history of psychosis, including visual hallucinations;
- History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
- Treatment for cancer in the last 5 years (excluding skin cancers);
- Major surgery in the last year;
- Treatment for a seizure disorder with anticonvulsants
- Current treatment with donepezil or any other AChEI or exposure within the last year.
- Treatment with opiates, muscle relaxants, or systemic steroids.
- In the opinion of the PI, treatment with AChEI is not appropriate due to a possible negative risk/benefit ratio based on past medical history or endorsement of symptoms during the screening interview.
- In the opinion of the treating physician, the patient must begin therapy with AChEI immediately due to any delays having an unacceptable impact on the patient's QoL.
- Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.
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 2026-04-14