NCT05592678Recruiting
δ in Dementia Clinical Trials
Novel Methods for Clinical Trials in Dementia and Cognitive Decline
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 13 Oct 2022
- Start date
- 5 Aug 2024
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Alzheimer disease
- NCT number
- NCT05592678
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 5 Aug 2024 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery in the last year;
- Current treatment with donepezil or any other AChEI or exposure within the last six months
- With a recently started Donepezil Rx (\< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.
Other illness
- A history of psychosis, including visual hallucinations;
- History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
- History of bradycardia or syncopal events;
- Treatment for cancer in the last 5 years (excluding skin cancers);
- Treatment for a seizure disorder with anticonvulsants;
Other
- Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);
- AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.
- Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.
Who the study is looking for
- Ambulatory outpatient volunteers with co-informants.
- Aged 65-100 years
- Clinical diagnosis of AD, or MCI.
- Capacity to give informed consent.
- GDS score (15 item) ≤ 8.
- No significant visual or hearing impairments
- Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.
Age in the registry: 65 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy of Texas Health Science Center at San Antonio (UTHSCSA) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.