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 with cognitive impairment will be treated for six-months with donepezil. 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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio