Expanded Access of Pimavanserin for Patients With PD Psychosis

Exclusion Criteria

• •1. Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
• •2. Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
• •3. Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
• •4. Patient has had a myocardial infarction in last six months
• •5. Patient has any surgery planned during the screening, treatment, or follow-up periods
• •Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).