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.
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.
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.
Parallel
12 cm2 - 2 Active DMTS Patches
Drug2 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)
6 cm2 - 1 Active and 1 Placebo DMTS Patches
Drug1 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)
Placebo - 2 Placebo DMTS Patches
Drug2 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)
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).
The ABS \[5\] is a 14-item scale developed to allow objective assessment of agitated behavior, particularly serial assessments for the evaluation of interventions to reduce agitation. The ABS Total Score ranges from 14 to 56. A total score of 21 or less is considered Normal; 22 to 28 is considered Mild; 29 to 35 Moderate; and 36 or more Severe Agitation.
Change in Clinical Global Impression Scale - Severity (CGI-S) score at 96 hours post-application (Day 5) relative to Pre-randomization (Day 1) baseline.
The CGI-S is a one item, 4-point (1-4) clinician-rated scale in which higher ratings indicate greater severity of agitation.
Change in ABS total score from baseline (Day -4 to Day -1 mean score) to the 168 hours post first application (Day 1 to Day 7).
The ABS \[5\] is a 14-item scale developed to allow objective assessment of agitated behavior, particularly serial assessments for the evaluation of interventions to reduce agitation.
Change in CGI-S score at 168 hours post application (Day 8) relative to Day 1 Pre-randomization baseline.
The CGI-S is a one item, 4-point (1-4) clinician-rated scale in which higher ratings indicate greater severity of agitation.
Percentage of subjects meeting the criteria for Day 15 DMTS/placebo application.
Number of subjects that meet the criteria for Day 15 dosing.
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