RecruitingPhase 2NCT06052254

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.

Enrollment

150 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests a skin patch that delivers a calming medication (dexmedetomidine) through the skin to treat agitation in people with Alzheimer's disease who live in care facilities. Agitation — including restlessness, aggression, and distress — is one of the most difficult symptoms of Alzheimer's to manage. **You may be eligible if...** - You (or your loved one) live in a care facility and have been diagnosed with probable Alzheimer's disease - You experience repeated episodes of agitation - A legally authorized representative can provide consent if needed **You may NOT be eligible if...** - You have a history of severe cardiovascular disease or uncontrolled low blood pressure - You are on medications that would interact unsafely with the study drug - You are pregnant - You have severe liver problems affecting drug metabolism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG12 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)

DRUG6 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)

DRUGPlacebo - 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)


Locations(3)

Elixia MA, LLC

Springfield, Massachusetts, United States

Vitalix

Worcester, Massachusetts, United States

BioBehavioral Health

Toms River, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT06052254


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