RecruitingAgitation
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
Eligible age
All ages
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Teikoku Pharma USA, Inc.
You may qualify if…
- ✓ 1. Voluntarily provide written informed consent (subject or legally authorized representative \[LAR\]).
- ✓ 2. Male or female, residing in a care facility.
- ✓ 3. Has a diagnosis of dementia of probable Alzheimer's Disease (AD) based on National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria (2018). The clinical diagnosis of "probable Alzheimer's Disease (AD)" will be based on the 2018 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria, which includes patient biomarker data as part of the research diagnosis (Jack et al., 2018). If patient biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria (McKhann et al., 2011).
- ✓ 4. Had two or more episodes (using a 7-day lookback period) of agitation that impairs social activities, requires staff or medical intervention, or impairs ability for functional activities of daily living at Screening.
- ✓ 5. Had an ABS total score ≥ 22 at least once during Day -4 to Day -1 when assessing eligibility on Day 1 Pre-randomization.
- ✓ 6. Has gone a minimum of 1 week with no change in medication prior to Screening.
- ✓ 7. Has a score of ≤ 23 on the Mini-Mental State Examination (MMSE) at Screening.
- ✓ 8. Female subjects who are:
You may not qualify if…
- ✕ 1. Has a known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo.
- ✕ 2. Has a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening.
- ✕ 3. Has a clinically significant abnormal clinical laboratory test value as determined by the investigator.
- ✕ 4. Has agitation caused by acute intoxication.
- ✕ 5. Has significant risk of suicide or homicide per investigator's assessment, or any patient with an answer of "yes" to Items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- ✕ 6. Has a history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- ✕ 7. Has a clinically significant history or clinically significant manifestation of any of the following, as determined by the investigator: a renal (including an estimated glomerular filtration rate \[eGFR\] below the appropriate age- and gender-specific range \[see Section 8.1.3.2\]), hepatic (including any evidence of ascites and/or a Child-Pugh hepatic impairment score \> 6 \[Appendix G\]), cardiovascular, metabolic, neurologic, or psychiatric condition; congestive heart failure, peptic ulcer, gastrointestinal bleeding, or other condition that may preclude participation in the study.
- ✕ 8. Has a history of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.
Where it's recruiting
Florida
Daytona Beach · Delray Beach · Miami · St. Petersburg
Massachusetts
Springfield · Worcester
New Jersey
Toms River
Source: ClinicalTrials.gov · NCT06052254 · last updated 2026-07-24