Evaluation of Dexmedetomidine Patches for Treating Agitation in Alzheimers Dementia Patients

What this Trial Is About

Researchers are evaluating the effects of Dexmedetomidine Transdermal Systems DMTS on reducing the frequency and severity of agitation in people with dementia of the Alzheimers type. This randomized, double-blind, placebo-controlled Phase 2 study compares DMTS to placebo to assess its potential in treating agitation symptoms associated with Alzheimers dementia. The study involves adult participants living in care facilities who meet specific diagnostic criteria and agitation severity requirements. Participants are randomly assigned to one of three groups two active DMTS patches, one active and one placebo patch, or two placebo patches applied to the upper back. Each patch application lasts for 4 days 96 hours, followed by a 14-day break. Eligible subjects may receive a second 4-day treatment period with the same assigned patches. This two-application design allows comparison of treatment effects over time. During the trial, participants undergo screening for eligibility up to 21 days before starting. Agitation and cognitive function are assessed using the Agitated Behavior Scale ABS, Clinical Global Impression Scale - Severity CGI-S, and Neuropsychiatric Inventory - Nursing Home Version NPI-NH. Researchers monitor participants throughout the treatment periods and follow-up assessments. The primary outcome is the change in ABS score from baseline to 96 hours after the first patch application. The total study duration includes screening, two treatment periods, and follow-up assessments extending to day 15.

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type