NCT06052254

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Teikoku Pharma USA, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized, double-blind, placebo-controlled, two application study of DMTS or matching placebo over a 4-day treatment period, followed 14 days later with the same treatment (active or placebo) for an additional 4-day treatment period for subjects that are eligible for second dosing. Eligible subjects will be screened up to 21 days prior to study start. Eligible subjects will be randomized 1:1:1 to treatment with 1 DMTS and 1 matching placebo, 2 DMTS, or 2 matching placebos.

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	12 cm2 - 2 Active DMTS Patches	2 Active DMTS patches applied to the upper back followed 14 days later by another application of 2 Active DMTS patches. Each application will be worn for 4 days (96 hours)
DRUG	6 cm2 - 1 Active and 1 Placebo DMTS Patches	1 Active and 1 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 1 Active and 1 Placebo DMTS patches. Each application will be worn for 4 days (96 hours)
DRUG	Placebo - 2 Placebo DMTS Patches	2 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 2 Placebo DMTS patches. Each application will be worn for 4 days (96 hours)

Timeline

• Start date: 2025-09-16
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-09-25
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study