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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Brexpiprazole

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 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