A Pragmatic Randomized Trial Comparing Pimavanserin and Quetiapine for Psychosis in Lewy Body Disease

What this Trial Is About

Psychosis, including hallucinations and delusions, is common in Parkinson's disease (PD) and dementia with Lewy bodies (DLB), collectively called Lewy body disease (LBD). These disorders cause movement, cognitive, and psychiatric symptoms, with psychosis affecting up to 60% of people with PD. This research aims to compare the effects of two antipsychotic medications, pimavanserin and quetiapine, in treating psychosis in LBD patients in a routine clinical setting. Participants will be randomly assigned to receive either pimavanserin or quetiapine. Both medications are atypical antipsychotics used to manage psychosis symptoms, with pimavanserin specifically indicated for hallucinations and delusions in Parkinson's disease and quetiapine commonly used for dementia-related psychosis. Dosage and medication management will follow routine clinical practice under the prescribing clinician's discretion. During the study, participants will be assessed for changes in psychosis symptoms over a six-month period using the Neuropsychiatry Inventory Questionnaire (NPI-Q) focusing on hallucinations and delusions. Additional evaluations include overall NPI-Q scores, anxiety, agitation, nighttime behaviors, mortality, medication discontinuation time, motor function assessments, and global impression scales. The study is designed to monitor participants closely over this timeframe to understand the comparative effects of these medications on psychosis in LBD.

Comparing Antipsychotic Medications in LBD Over Time