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

NCT06052254 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Agitation

Interventions

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)

Sponsors & Collaborators

  • Teikoku Pharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Tami Ujiie · Teikoku Pharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052254 on ClinicalTrials.gov