NCT02168920

Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Agitation Associated With Dementia of the Alzheimer's Type

Interventions

Type	Name	Description
DRUG	2 mg/day	Once daily for 10 weeks
DRUG	3 mg/day	Once daily for 10 weeks
DRUG	6 mg/day	Once daily for 10 weeks
DRUG	Placebo (0 mg/day)	Once daily for 10 weeks

Timeline

• Start date: 2014-06-11
• Primary completion: 2016-03-18
• Completion: 2016-03-18
• First posted: 2014-06-20
• Last updated: 2017-10-16

Locations

1 site across 1 country: Japan