Agitation in Patients With Dementia of the Alzheimer's Type
Conditions
Brief summary
The primary efficacy endpoint is the change from baseline to the end of the efficacy period in the CMAI total score.
Detailed description
The key secondary efficacy variable is the change from baseline to end of efficacy period in the CGI-S score, as related to agitation. It will be analyzed by the same statistical methodology specified for the analysis of the primary efficacy variable. The procedure to control the overall type I error rate for this key secondary efficacy analysis will be described in the SAP.
Interventions
DRUGAVP-786
Sponsors
Otsuka Pharmaceutical Development & Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the change from baseline to the end of the efficacy period in the CMAI total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy variable is the change from baseline to end of efficacy period in the CGI-S score, as related to agitation. It will be analyzed by the same statistical methodology specified for the analysis of the primary efficacy variable. The procedure to control the overall type I error rate for this key secondary efficacy analysis will be described in the SAP. | — |
Countries
Bulgaria, Denmark, Estonia, Germany, Greece, Poland, Portugal
Outcome results
None listed