Actively Recruiting
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
Led by Teikoku Pharma USA, Inc. · Updated on 2026-04-13
150
Participants Needed
3
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily provide written informed consent (subject or legally authorized representative).
- Male or female residing in a care facility.
- Diagnosis of probable Alzheimer's Disease dementia based on 2018 NIA-AA criteria or 2011 NIA-AA criteria if biomarker data unavailable.
- Two or more episodes of agitation within a 7-day period affecting social or functional activities at screening.
- Agitated Behavior Scale total score of 22 or higher at least once during days -4 to -1 before randomization.
- Stable medication doses for at least 1 week prior to screening.
- Mini-Mental State Examination score of 23 or less at screening.
- Female subjects must not be pregnant or lactating and meet specific contraception or sterilization requirements.
- Male subjects with female partners of childbearing potential must use reliable birth control during and 1 month after the study.
- Body weight over 50 kg and body mass index between 20 and 38 kg/m2 inclusive.
- Ability to understand study procedures and comply for the entire study duration.
- Resided in the facility at least 7 days prior to screening and will remain through follow-up.
You will not qualify if you...
- Known sensitivity to dexmedetomidine or any patch excipients.
- Skin abnormalities or unhealthy skin at the patch application site.
- Clinically significant abnormal lab test results.
- Agitation due to acute intoxication.
- Significant risk of suicide or homicide or positive on Columbia-Suicide Severity Rating Scale items 4 or 5.
- History or positive test for HIV, hepatitis B, or hepatitis C.
- Significant renal, hepatic, cardiovascular, metabolic, neurologic, or psychiatric conditions.
- History of migraine, frequent headaches, seizures, or current anticonvulsant use.
- History of syncope or syncopal attacks.
- Present or significant history of postural hypotension or severe dizziness/fainting on standing.
- Clinically significant ECG abnormalities.
- Heart rate outside 60-100 bpm or blood pressure outside specified ranges measured in multiple positions.
- History of alcohol or drug abuse within 5 years.
- Positive drug or alcohol tests at screening.
- Concurrent therapy interfering with study evaluations (some stable medications permitted).
- Use of certain natural health products within 7 days prior and during study unless approved.
- Recent upper respiratory tract infection or corticosteroid use (oral/injectable) within 7 days.
- Receipt of investigational product within 30 days prior.
- Previous participation in DMTS clinical trials.
- Johns Hopkins Fall Risk Assessment Score over 13.
- Considered unsuitable or unlikely to comply with the study protocol by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Elixia MA, LLC
Springfield, Massachusetts, United States, 01103
Withdrawn
2
Vitalix
Worcester, Massachusetts, United States, 01608
Actively Recruiting
3
BioBehavioral Health
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
T
Tami Ujiie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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