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

NCT02168920 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-10-16

No results posted yet for this study

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

Conditions

  • Agitation Associated With Dementia of the Alzheimer's Type

Interventions

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-11
Primary Completion
2016-03-18
Completion
2016-03-18

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168920 on ClinicalTrials.gov