A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson’s Disease Psychosis

Abstract Introduction Accurate assessment of disability associated with Parkinson’s Disease Psychosis (PDP) is essential and has been poorly studied. Patients often have poor insight on impact PDP daily function. This phase 4 study the first to evaluate pimavanserin activities living (ADL) in patients. Methods Eligible patients entered a 16-week single-arm, open-label oral (34 mg) taken once daily. Primary endpoint (modified Functional Status Questionnaire [mFSQ]) secondary endpoints (MDS-UPDRS I & II; Schwab England ADL; CGI-S, CGI-I, PGI-I) were measured as change from baseline Week 16 using mixed-effects model for repeated measures (MMRM) least-squares means (LSM). Results 29 treated pimavanserin, which 24 (82.8%) completed study. Treated demonstrated significant improvements LSM (SE) mFSQ score 12 (11.5 [2.44]) (14.0 [2.50]; both p<0.0001). Significant (p<0.05) also observed all outcomes at Part I: -6.3 [0.97]; MDS-UPDRS II: -2.6 [0.98]; CGI-S: -1.5 [0.25]; CGI-I: 1.9 [0.17]; PGI-I: 2.0 [0.22], except ADL. No new safety signals observed. Conclusion psychosis improved findings consistent previous studies. Our highlight positive effect improving ADLs PDP. Funding Acadia Pharmaceuticals Inc.