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

This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled,
fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole
compared with placebo. The trial consists of a 12-week double-blind treatment period with a
30 day follow-up. The trial population will include male and female subjects between 55 and
90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are
residing either in an institutionalized setting or in a non-institutionalized setting where
the subject is not living alone. This trial will analyze data gathered from 225 subjects at
multiple countries. Subjects may also be eligible to enter an active extension trial,
following completion of this trial.

Inclusion Criteria:

- 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.