A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer’s Type

– Subjects with a diagnosis of probable Alzheimer’s disease.

– Subjects with a diagnosis of agitation

– Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.

– Subjects with a previous MRI or CT scan of the brain, that was performed after the
onset of symptoms of dementia, with findings consistent with a diagnosis of
Alzheimer’s disease.

– Subjects who are residing at their current location for at least 28 days before
screening and are expected to remain at the same location for the duration of the
trial.

– Institutionalized subjects with an identified caregiver who has sufficient contact
(minimum of 2 hours per day for 4 days per week) to describe the subject’s symptoms
and has direct observation of the subject’s behavior. Non-institutionalized subjects
may not be living alone and must have an identified caregiver who has sufficient
contact (minimum of 2 hours per day for 4 days per week) to describe the subject’s
symptoms and has direct observation of the subject’s behavior.

– Subjects with onset of symptoms of agitation at least 2 weeks prior to screening
visit.

– Subjects will and able to discontinue all prohibited concomitant medications to meet
protocol required washouts prior to and during the trial period.

Exclusion Criteria:

– Subjects with dementia or other memory impairment not due to Alzheimer’s disease.

– Subjects with a history of stroke, well-documented transient ischemic attack, or
pulmonary or cerebral embolism.

– Subjects who had an insufficient response, based on the investigator’s judgment, to 2
or more previous antipsychotic medications.

– Subjects who have been diagnosed with an Axis I disorder.

– Subjects who currently have clinically significant neurological, hepatic, renal,
metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,
or psychiatric disorders.

– Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic
hypotension.

– Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be
eligible for the trial if their condition is stable and well-controlled.