RecruitingNot ApplicableNCT05592678

δ in Dementia Clinical Trials

Novel Methods for Clinical Trials in Dementia and Cognitive Decline


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

200 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 65 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how to better measure cognitive decline in people with Alzheimer's disease or mild cognitive impairment, with a focus on finding more sensitive tools for use in clinical trials. It is an observational study — participants will complete assessments but not receive experimental treatment. **You may be eligible if...** - You are 65–100 years old - You have been diagnosed with Alzheimer's disease or mild cognitive impairment (MCI) - You have a caregiver or informant who spends at least 5 hours per week with you and can provide information about your cognition - You are able to give informed consent **You may NOT be eligible if...** - You have a history of psychosis or visual hallucinations - You have Parkinson's disease, tremor, or REM sleep behavior disorder - You have atrial fibrillation, chronic diarrhea, or have had colon surgery - You have been treated for cancer in the last 5 years (not counting skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDonepezil

Donepezil is administered as a standard of care treatment by the subject's provider.


Locations(1)

Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)

San Antonio, Texas, United States

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NCT05592678


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