A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Status: | Recruiting |
---|---|
Conditions: | Alzheimer Disease, Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - 91 |
Updated: | 1/19/2019 |
Start Date: | October 12, 2018 |
End Date: | August 2021 |
A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and
tolerability of oral brexpiprazole as treatment in adult subjects with agitation associated
with dementia of the Alzheimer's type (AAD).
tolerability of oral brexpiprazole as treatment in adult subjects with agitation associated
with dementia of the Alzheimer's type (AAD).
Inclusion Criteria:
- Subject must complete 12 weeks of prior treatment in the 331-14-213 study.
- Subject must have an identified caregiver who has contact, at a minimum of 2 hours per
day, 4 days per week to describe the subject's symptoms and can observe subject
behavior.
Exclusion Criteria:
- Subjects with a substantial protocol violation during the course of their
participation in the double-blind trial 331-14-213.
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