Both Male and Female ages 50 Years to 90 Years
Key Inclusion Criteria:
Diagnosis of probable Alzheimer's disease (AD).
The patient has clinically significant symptoms of agitation secondary to AD, that
interfere with daily routine and for which a prescription medication is deemed indicated,
in the opinion of the investigator.
Either out-patients or residents of an assisted-living facility or a skilled nursing home.
CGI-S score is ≥ 4 (moderately ill) at screening and baseline.
Mini Mental State Examination (MMSE) score at screening between 8 and 26(inclusive).
Caregiver who is able and willing to comply with all required study procedures, ensuring
that the patient attends all study visits and takes the study medication as instructed.
Caregiver must spend time with the patient a minimum of 4 times per week on 4 separate
Key Exclusion Criteria:
Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia,
Parkinson's disease, substance-induced dementia).
Patients with co-existent clinically significant or unstable systemic diseases that could
confound the interpretation of the safety results of the study (e.g. malignancy, poorly
controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic
disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac
conduction abnormalities including QTc prolongation, or unstable valvular heart disease).
Patients with myasthenia gravis.