A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
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ClinicalTrials.gov Identifier: NCT03594123 |
Recruitment Status :
Recruiting
First Posted : July 20, 2018
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Brexpiprazole | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type |
Actual Study Start Date : | October 12, 2018 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Brexpiprazole Arm 1
Oral tablet; taken once daily. Total daily dose of 2 mg/day
|
Drug: Brexpiprazole
2 mg tablet |
Experimental: Brexpiprazole Arm 2
Oral tablet; taken once daily. Total daily dose of 3 mg/day
|
Drug: Brexpiprazole
3 mg tablet |
- Adverse Events (AEs) [ Time Frame: Up to 16 weeks ]Frequency and severity of AEs will be reviewed to determine safety and tolerability of brexpiprazole

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Ages Eligible for Study: | 55 Years to 91 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must have participated in the 331-14-213 study.
- Subject must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the subject's symptoms and can observe subject behavior.
Exclusion Criteria:
- Subjects with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

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): NCT03594123
Contact: Otsuka Call Center | 844-687-8522 | OtsukaUS@druginfo.com |
United States, Florida | |
For additional information regarding sites, contact 844-687-8522 | Recruiting |
Miami, Florida, United States, 33155 |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT03594123 |
Other Study ID Numbers: |
331-201-00182 |
First Posted: | July 20, 2018 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Agitation |
Alzheimer Disease Dementia Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders 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 |