Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

Inclusion Criteria

• •1. Male or female, 50 years of age or older
• •2. Can understand the nature of the trial and protocol requirements and provide signed informed consent
• •* from patient, if deemed competent to provide consent
• •* from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
• •3. Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
• •4. Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
• •5. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
• •6. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
• •7. Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
• •8. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests