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

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

Study Overview

• Status: Completed
• Conditions: Agitation Associated With Dementia of the Alzheimer's Type
• Intervention / Treatment: Drug: Brexpiprazole; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Drug Information Center; Phone Number: +81-3-6361-7314

Study Locations

• Japan
  • Shirakawa, Japan
    • Jisenkai Nanko Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who satisfy both of the following diagnostic criteria:

  1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
  2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.
• Hospitalized patients or care facility patients or care at home patients
• Patients with an MMSE score of 1 to 22
• Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion Criteria:

• Patients who have dementia other than dementia of the Alzheimer's type
• Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.

• Patients diagnosed with any of the following disorders according to DSM-5:

  • Schizophrenia spectrum and other psychotic disorders
  • Bipolar and related disorders
  • Major depressive disorder

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brexpiprazole, 1mg/day; Drug: 1mg/day Once daily for 10 weeks	Drug: Brexpiprazole; Drug: 1 tablet /day Once daily for 10 weeks
Experimental: Brexpiprazole, 2mg/day; Drug: 2mg/day Once daily for 10 weeks	Drug: Brexpiprazole; Drug: 1 tablet /day Once daily for 10 weeks
Placebo Comparator: Placebo; Drug: Placebo (0mg/day) Once daily for 10 weeks	Drug: Placebo; Placebo: 1 tablet /day Once daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks	Baseline, 10 weeks after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in CMAI score at 10 weeks	Baseline, 10 weeks after dosing
Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks	Baseline, 10 weeks after dosing

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: August 5, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• 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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Brexpiprazole
• Other Study ID Numbers: 331-102-00088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No