NCT05592678 · The University of Texas Health Science Center at San Antonio
δ in Dementia Clinical Trials
(δND)
What this study is about
The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline.
View original scientific description
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.
Interventions
OTHER
Donepezil
Donepezil is administered as a standard of care treatment by the subject's provider.
Primary outcome measures
dTEL change
Time frame: At baseline, and weeks 4, 12 and 24.
Change in a latent dementia-specific phenotype derived from cognitive assessment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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);
- Major surgery in the last year;
- Treatment for a seizure disorder with anticonvulsants;
- Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);
- 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.
- 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.
Where
- San Antonio, Texas
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations