Actively Recruiting
A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Agitation Associated With Dementia of the Alzheimer's Type
Led by Teikoku Pharma USA, Inc. · Updated on 2026-05-28
150
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Dexmedetomidine Transdermal Systems (DMTS) in reducing how often and how severe agitation occurs in people with dementia of the Alzheimer's type. This study is a Phase 2, randomized, double-blind, placebo-controlled trial comparing DMTS to a placebo patch. The goal is to better understand how DMTS affects agitation symptoms in this population. Participants will be randomly assigned to one of three groups: two active DMTS patches, one active and one placebo patch, or two placebo patches. The patches are applied to the upper back and worn for 4 days (96 hours). After 14 days, eligible participants receive the same treatment again for another 4-day period. The study includes two treatment periods separated by a 14-day gap. During the study, participants will be monitored for changes in agitation using the Agitated Behavior Scale (ABS) over the first 4 days and up to 7 days after application. Other assessments include the Clinical Global Impression Scale - Severity (CGI-S) and the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). Safety and adherence will be tracked throughout, and follow-up assessments will confirm continued participation. The total study duration includes screening up to 21 days before treatment starts and follow-up after the second application.
CONDITIONS
Brief 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...
- Provide written informed consent yourself or via a legally authorized representative.
- Male or female residing in a care facility.
- Diagnosed with probable Alzheimer's disease dementia based on 2018 or 2011 NIA-AA criteria.
- Experienced two or more episodes of agitation within 7 days that affect social activities, require intervention, or impair daily living.
- Agitated Behavior Scale (ABS) total score of 22 or higher at least once during eligibility assessment.
- Stable medication regimen with no changes for at least 1 week prior to screening.
- Mini-Mental State Examination (MMSE) score of 23 or less at screening.
- Female participants must not be pregnant, lactating, or planning pregnancy and must use effective contraception or meet specific criteria.
- Male participants with female partners of childbearing potential must use reliable birth control.
- Body weight over 50 kg and body mass index between 20 and 38 kg/m2.
- Able to understand and comply with study procedures and commit to full study duration.
- Lived in the care facility for at least 7 days before screening and will remain for 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 tests.
- Agitation caused by acute intoxication.
- High risk of suicide or homicide or positive Columbia-Suicide Severity Rating Scale on key items.
- History or positive test for HIV, hepatitis B, or hepatitis C.
- Significant renal, hepatic, cardiovascular, metabolic, neurologic, or psychiatric conditions.
- History of migraine, frequent non-vascular headaches, seizures, or use of anticonvulsants.
- History of syncope or significant postural hypotension or severe dizziness on standing.
- Clinically significant ECG abnormalities or abnormal heart rate or blood pressure measurements.
- History of alcohol or drug abuse within past 5 years or positive drug/alcohol screening.
- Use of medications or natural products that may interfere with study or safety unless stable and approved.
- Recent upper respiratory infection or corticosteroid use (oral/injectable) within 7 days prior to dosing.
- Prior participation in DMTS clinical trials.
- Johns Hopkins Fall Risk Assessment Score over 13.
- Considered unsuitable or unlikely to comply with study protocol by investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 22 days total including treatment and break periods
Participants receive one of three possible patch treatments applied to the upper back. Each treatment application is worn for 4 days (96 hours), followed by a 14-day break and then a second 4-day treatment for eligible participants.
2 treatment periods of 4 days each with a 14-day interval in between
Trial Site Locations
Total: 4 locations
1
Professional Health Care of Pinellas, LLC
St. Petersburg, Florida, United States, 33713
Actively Recruiting
2
Elixia MA, LLC
Springfield, Massachusetts, United States, 01103
Withdrawn
3
Vitalix
Worcester, Massachusetts, United States, 01608
Actively Recruiting
4
BioBehavioral Health
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
T
Tami Ujiie
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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