A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

Inclusion Criteria:

• Participants with a diagnosis of probable Alzheimer's disease.
• Participants with a diagnosis of agitation
• Participants with a MMSE score of 5 to 22, inclusive, at screening and baselinevisits.
• Participants with a previous MRI or CT scan of the brain, that was performed after theonset of symptoms of dementia, with findings consistent with a diagnosis ofAlzheimer's disease.
• Participants who are residing at their current location for at least 28 days beforescreening and are expected to remain at the same location for the duration of thetrial.
• Institutionalized participants with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the participant'ssymptoms and has direct observation of the participant's behavior.Non-institutionalized participants may not be living alone and must have an identifiedcaregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week)to describe the participant's symptoms and has direct observation of the participant'sbehavior.
• Participants with onset of symptoms of agitation at least 2 weeks prior to screeningvisit.
• Participants will and able to discontinue all prohibited concomitant medications tomeet protocol required washouts prior to and during the trial period.

Exclusion Criteria:

• Participants with dementia or other memory impairment not due to Alzheimer's disease.
• Participants with a history of stroke, well-documented transient ischemic attack, orpulmonary or cerebral embolism.
• Participants who had an insufficient response, based on the investigator's judgment,to 2 or more previous antipsychotic medications.
• Participants who have been diagnosed with an Axis I disorder.
• Participants who currently have clinically significant neurological, hepatic, renal,metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,or psychiatric disorders.
• Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatichypotension.
• Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) maybe eligible for the trial if their condition is stable and well-controlled.