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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kanto Region, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (0 mg/day); Once daily for 10 weeks
Experimental: Aripiprazole, 2 mg/day	Drug: 2 mg/day; Once daily for 10 weeks
Experimental: Aripiprazole, 3 mg/day	Drug: 3 mg/day; Once daily for 10 weeks
Experimental: Aripiprazole, 6 mg/day	Drug: 6 mg/day; Once daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMAI	Change from baseline	Baseline, 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Severity （CGI-S）	Change from baseline	Baseline, 10 weeks
Clinical Global Impression-Improvement (CGI-I)	Score after 10 weeks	10 Weeks

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2014
• Primary Completion (Actual): March 18, 2016
• Study Completion (Actual): March 18, 2016

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Alzeheimer
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Tauopathies; Psychomotor Agitation; Dementia; Alzheimer Disease
• Other Study ID Numbers: 031-13-001