Phase 2RecruitingAge-related condition
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Agitation Associated With Dementia of the Alzheimer's Type
- Sponsor
- Teikoku Pharma USA, Inc. (Industry)
- Enrolment
- 150 planned
- Conditions
- Agitation
- Interventions
- 12 cm2 - 2 Active DMTS Patches; 6 cm2 - 1 Active and 1 Placebo DMTS Patches; Placebo - 2 Placebo DMTS Patches
- Ages
- children, adults, older adults
- Registry
- NCT06052254
Full record on ClinicalTrials.gov
From the registry
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
Primary outcomes
- Change in Agitated Behavior Scale (ABS) total score from baseline (Day -4 to Day -1 mean score) to the 96 hours of first application (Day 1 to Day 4).
History
Primary completion expected
Last registry update
Started
Registered