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.

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