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

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ClinicalTrials.gov Identifier: NCT03724942
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Condition or disease Intervention/treatment Phase
Agitation Associated With Dementia of the Alzheimer's Type Drug: Brexpiprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 157 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brexpiprazole Drug: Brexpiprazole
Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks
Other Name: OPC-34712


Outcome Measures
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Primary Outcome Measures :
  1. The frequency of Adverse events [ Time Frame: From baseline to week 14 ]

Secondary Outcome Measures :
  1. Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing [ Time Frame: Baseline and 14 weeks after dosing ]
  2. Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing [ Time Frame: Baseline and 14 weeks after dosing ]
  3. Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing [ Time Frame: Baseline and 14 weeks after dosing ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
  • Patients whose caregiver can properly collect the necessary information.

Exclusion Criteria:

  • Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
  • Patients who had delirium during the double-blind trial.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724942


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Jisenkai Nanko Psychiatric Institute Recruiting
Shirakawa, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03724942    
Other Study ID Numbers: 331-102-00184
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
 Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents