To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory \[CMAI\] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia
This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparison trial to assess the efficacy and safety of aripiprazole in patients with agitation associated with Alzheimer's type dementia. Screening period is 4 weeks. Patients are randomly assigned to one of 4 groups, and treatment period is 10 weeks. Period of post-treatment observation is 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Unnamed facility
Kanto Region, Japan
CMAI
Change from baseline
Time frame: Baseline, 10 weeks
Clinical Global Impression of Severity (CGI-S)
Change from baseline
Time frame: Baseline, 10 weeks
Clinical Global Impression-Improvement (CGI-I)
Score after 10 weeks
Time frame: 10 Weeks
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Once daily for 10 weeks