Novel Methods for Clinical Trials in Dementia and Cognitive Decline

What this Trial Is About

Researchers are investigating new methods for clinical trials in dementia and cognitive decline, focusing on whether a combined measure called "b4," which integrates cognitive performance and functional status, can better assess intervention outcomes. The study explores if biomarkers called adipokines in the blood can guide selecting patients likely to respond to donepezil, a medication approved for Alzheimer's Disease. The trial also examines if changes in these biomarkers mediate the effect of the intervention on dementia severity. Participants with cognitive impairment and their caregivers will be interviewed by phone to predict their response to donepezil. Based on this prediction, participants will be assigned to groups of predicted responders or non-responders. Donepezil, prescribed by their healthcare providers as standard care, will be studied in these groups. The trial does not randomize participants but uses an algorithm to assign groups. This study spans 24 weeks, with assessments at baseline, weeks 4, 12, and 24. During the study, participants and caregivers will provide information remotely, and blood samples will be collected to measure adipokine levels. Researchers will track changes in dementia severity using the latent variable "b4" at scheduled visits. Safety and treatment effects will be monitored throughout. The total participation lasts about six months, during which donepezil’s impact on dementia and biomarker changes will be evaluated.

δ in Dementia Clinical Trials