Psychosis affects over half of people with Parkinson disease (PDP) and can erode quality of life, cognition, activities of daily living (ADLs), and overall function. Yet, functional outcomes are rarely measured in PDP trials. Building on a prior phase 4 study that used a modified Functional Status Questionnaire (mFSQ), this post hoc analysis evaluated mFSQ subscales as patient-reported outcomes and examined the impact of pimavanserin on ADLs and functional status. The analysis emphasized patient-reported function to capture changes not fully reflected by motor scales.
In patients with PDP treated with pimavanserin (n=29), least-squares mean change from baseline to week 16 showed improvements across all five mFSQ domains (basic ADL, intermediate ADL, psychological function, quality of interaction, social activity), with the largest gain in social activity (least-squares mean 25.8 [SE 7.52]; 95% CI 10.2–41.5; p=0.0026). Other domains showed numerically smaller but consistent improvements, suggesting a broad functional signal beyond social participation. mFSQ scores correlated positively with both patient- and caregiver-rated Schwab and England ADL scales, supporting mFSQ’s validity as a functional patient-reported outcome. Given the small sample and post hoc design, larger prospective studies are needed. The authors propose using the mFSQ alongside Schwab and England in trials and clinical practice to monitor functional response to pimavanserin and other therapies.
Reference: Evidente VGH, Chrones L, Revankar R, et al. The Modified Functional Status Questionnaire for Assessing Patients with Parkinson’s Disease Psychosis Treated with Pimavanserin: A Post Hoc Analysis. Neurol Ther. 2025;14(4):1299-1309. doi: 10.1007/s40120-025-00757-3.
