RecruitingPhase 2

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

United States150 participantsStarted 2025-09-16

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. Voluntarily provide written informed consent (subject or legally authorized representative \[LAR\]).
✓. Male or female, residing in a care facility.
✓. 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).
✓. 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.
✓. Had an ABS total score ≥ 22 at least once during Day -4 to Day -1 when assessing eligibility on Day 1 Pre-randomization.
✓. Has gone a minimum of 1 week with no change in medication prior to Screening.
✓. Has a score of ≤ 23 on the Mini-Mental State Examination (MMSE) at Screening.
✓. Female subjects who are:

Exclusion criteria

✕. Has a known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo.
✕. 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.
✕. Has a clinically significant abnormal clinical laboratory test value as determined by the investigator.
✕. Has agitation caused by acute intoxication.
✕. 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).
✕. Has a history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
✕. 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.
✕. Has a history of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.

What they're measuring

Change in Agitated Behavior Scale (ABS) total score from baseline (Day -4 to Day -1 mean score) to the 96 hours of first application (Day 1 to Day 4).

Timeframe: Baseline (Day -4 to Day -1) to 96 hours after first application (Day 1 to Day 4)

Trial details

NCT IDNCT06052254

SponsorTeikoku Pharma USA, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Tami Ujiie

408-501-1822 tujiie@teikokuusa.com

View on ClinicalTrials.gov More Agitation trials