δ in Dementia Clinical Trials

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05592678
Status
Recruiting
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Conditions

  • Alzheimer's Disease (AD)
  • Cognitive Decline
  • Dementia
  • Mild Cognitivie Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
65 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 5, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Predicted Responders
    Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.
  • Other: Predicted Non-Responders
    Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.

Primary Outcome Measure

dTEL change [ Time Frame: At baseline, and weeks 4, 12 and 24. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)San AntonioTexas78229-3900
Samuel Guess
[email protected]
210 567 8133
Floyd Jones
[email protected]
[email protected]

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

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