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

Phase 3

Terminated

• Conditions: Agitation Associated With Dementia of the Alzheimer's Type
• Interventions: Drug: 3 mg/day; Drug: 6 mg/day; Drug: 2 mg/day; Drug: Placebo (0 mg/day)

• Registration Number: NCT02168920
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2014-06-11
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Primary Completion: 2016-03-18
• Study Completion: 2016-03-18
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).

• Patients who satisfy both of the following diagnostic criteria:

  • Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5)
  • Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

• Hospitalized patients or care facility patients

• Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22

Exclusion Criteria

• Patients with complications of dementia or memory impairment other than Alzheimer's type dementia
• Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher
• Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances
• Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke
• Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV
• Patients who require drug therapy for arrhythmia or ischemic heart disease
• Body weight of less than 30 kg
• Patients with a high risk of suicide
• Patients with a complication or history of seizure disorder
• Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis
• Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole, 3 mg/day	3 mg/day	-
Aripiprazole, 6 mg/day	6 mg/day	-
Aripiprazole, 2 mg/day	2 mg/day	-
Placebo	Placebo (0 mg/day)	-

Primary Outcome Measures

Name	Time	Method
CMAI	Baseline, 10 weeks	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement (CGI-I)	10 Weeks	Score after 10 weeks
Clinical Global Impression of Severity （CGI-S）	Baseline, 10 weeks	Change from baseline