Objective: To examine the effects of pimavanserin on activities of daily living during treatment for Parkinson’s Disease psychosis.

Background: 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 of PDP on daily function. This phase 4 study is the first to evaluate the impact of pimavanserin on activities of daily living (ADL) in PDP patients.

Method: Eligible PDP patients entered a 16-week single-arm, open-label study of oral pimavanserin (34 mg) taken once daily. Primary endpoint (modified Functional Status Questionnaire [mFSQ]) and secondary endpoints (MDS-UPDRS I & II; Schwab and England ADL; CGI-S, CGI-I, and PGI-I) were measured as change from baseline to Week 16 using mixed-effects model for repeated measures (MMRM) and least-squares means (LSM).

Results: 29 patients were treated with pimavanserin, of which 24 (82.8%) completed the study. Treated patients demonstrated significant improvements in LSM (SE) mFSQ score change from baseline to Week 12 (11.5 [2.44]) and Week 16 (14.0 [2.50]; both p<0.0001). Significant improvements (p<0.05) were also observed for all secondary outcomes at Week 16 (MDS-UPDRS Part I: -6.3 [0.97]; MDS-UPDRS Part II: -2.6 [0.98]; CGI-S: -1.5 [0.25]; CGI-I: 1.9 [0.17]; PGI-I: 2.0 [0.22], except for Schwab and England ADL. No new safety signals were observed.

Conclusion: Functional outcomes and psychosis measures improved in PDP patients treated with pimavanserin, with safety findings consistent with previous studies. Our findings highlight the positive effect of pimavanserin in improving ADLs in patients with PDP.

Previously presented at Psych Congress Sept 17-20, 2022

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-16-week-open-label-study-of-the-effects-of-treatment-with-pimavanserin-on-activities-of-daily-living-in-subjects-with-parkinsons-disease-psychosis-pdp/