Brexpiprazole for the long-term treatment of patients with agitation associated with dementia of the Alzheimer's type
- Conditions
- Agitation Associated With Dementia of the Alzheimer's Type
- Registration Number
- JPRN-jRCT2080224118
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Brexpiprazole administered at doses of 1 mg and 2 mg once daily for 14 weeks in patients with agitation associated with dementia of the Alzheimer`s type who completed the 10-week treatment period of Trial 331-102-00088 provided sustained therapeutic effect and was well tolerated with no outcomes suggestive of a significant impact on safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 164
1. Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
2. Patients whose caregiver can properly collect the necessary information.
1. Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
2. Patients who had delirium during the double-blind trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method