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Clinical Trial Summary

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


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02168920
Study type Interventional
Source Otsuka Pharmaceutical Co., Ltd.
Contact
Status Terminated
Phase Phase 3
Start date June 11, 2014
Completion date March 18, 2016

See also
  Status Clinical Trial Phase
Completed NCT03724942 - Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type Phase 3
Completed NCT03620981 - Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type Phase 2/Phase 3