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Trial record 38 of 64 for:    brexpiprazole

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

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ClinicalTrials.gov Identifier: NCT03620981
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Agitation Associated With Dementia of the Alzheimer's Type Drug: Brexpiprazole Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021


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




Primary Outcome Measures :
  1. Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks [ Time Frame: Baseline, 10 weeks after dosing ]

Secondary Outcome Measures :
  1. Mean change from baseline in CMAI score at 10 weeks [ Time Frame: Baseline, 10 weeks after dosing ]
  2. Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 10 weeks [ Time Frame: Baseline, 10 weeks after dosing ]


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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 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 with delirium and patients who had delirium within 30 days before the screening examination
  • Patients diagnosed with any of the following disorders according to DSM-5:

    1. Schizophrenia spectrum and other psychotic disorders
    2. Bipolar and related disorders
    3. Major depressive disorder

Information from the National Library of Medicine

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): NCT03620981


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.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03620981     History of Changes
Other Study ID Numbers: 331-102-00088
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Brexpiprazole
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
Signs and Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents