A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Inclusion Criteria

• •1. Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
• •1. The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
• •2. The subject must provide written (if capable) informed assent
• •2. Subject requires some or complete assistance with one or more of the following:
• •1. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
• •2. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
• •3. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):
• •1. Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
• •2. Dementia with Lewy bodies (DLB)
• •3. All-cause dementia, possible or probable Alzheimer's disease (AD)
• •4. Frontotemporal degeneration spectrum disorders, including possible or probable:
• •i. Behavioral variant frontotemporal dementia
• •ii. Progressive supranuclear palsy
• •iii. Corticobasal degeneration
• •e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)
• •4. Has a designated study partner/caregiver
• •5. Can come to the clinic for study visits with a study partner/caregiver
• •6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent.
• •7. If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)