Teikoku Pharma USA, Inc.
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.
This is a randomized, double-blind, placebo-controlled, two application study of DMTS or matching placebo over a 4-day treatment period, followed 14 days later with the same treatment (active or placebo) for an additional 4-day treatment period for subjects that are eligible for second dosing. Eligible subjects will be screened up to 21 days prior to study start. Eligible subjects will be randomized 1:1:1 to treatment with 1 DMTS and 1 matching placebo, 2 DMTS, or 2 matching placebos.
Inclusion Criteria: 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). I…
2 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)
1 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)
2 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)