Dexmedetomidine Transdermal Systems (DMTS) for Agitation in Alzheimer's Disease
This study is testing a skin patch called Dexmedetomidine Transdermal Systems (DMTS) to see if it can help reduce agitation in people with Alzheimer's disease. Participants will receive either two active DMTS patches, one active and one placebo (inactive) patch, or two placebo patches. These patches are worn on the upper back for 4 days, and then the same treatment is repeated 14 days later for another 4 days. The main goal is to see if DMTS can improve agitation levels compared to the placebo. The study plans to enroll 150 people who have been diagnosed with probable Alzheimer's disease and live in a care facility.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to a treatment group and neither they nor their doctors will know if they are receiving the active drug or a placebo. The study aims to enroll 150 participants.
- What's involved
- Participants will wear patches on their upper back for 4 days, followed by a 14-day break, and then wear patches again for another 4 days. There will be a screening period up to 21 days before the study starts.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes in agitation from baseline up to 96 hours after the first application of patches.
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Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
At a glance
Conditions
Where it's being run
8 sites across 3 statesStudy leadership
- Tami Ujiie · STUDY_DIRECTOR · Teikoku Pharma USA, Inc.
Who to contact
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What this trial measures
- 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).Baseline (Day -4 to Day -1) to 96 hours after first application (Day 1 to Day 4)
The ABS \[5\] is a 14-item scale developed to allow objective assessment of agitated behavior, particularly serial assessments for the evaluation of interventions to reduce agitation. The ABS Total Score ranges from 14 to 56. A total score of 21 or less is considered Normal; 22 to 28 is considered Mild; 29 to 35 Moderate; and 36 or more Severe Agitation.