Use of the Modified Functional Status Questionnaire to Assess Functioning in Patients with Parkinson’s Disease Psychosis Treated with Pimavanserin
Nazia Rashid1, Lambros Chrones1, Ratna Revankar1, Dilesh Doshi1, Victor Abler2, Virgilio Gerald Evidente3
1Acadia Pharmacetuicals, 2Acadia Pharmaceuticals, 3Movement Disorders Center of Arizona
Objective:
In this analysis, we provide additional data on the patient-reported mFSQ within specific domains.
Background:
Individuals with Parkinson's disease psychosis (PDP) face functional limitations associated with worsening hallucinations and delusions. Assessing activities of daily living (ADLs) and functioning of PDP patients can help inform PDP treatment. Prior results were reported from a Phase 4 open-label study examining the impact of pimavanserin on ADLs and functioning in patients with PDP which utilized a modified version of the Functional Status Questionnaire (mFSQ) as the primary outcome measure.
Design/Methods:
Eligible patients entered a 16-week single-arm, open-label study of once-daily oral pimavanserin (34mg). The 6-domain FSQ was modified to assess 5 domains by removing the Work/Performance domain since this was not applicable to the patients in this study. The mean change from baseline to week 16 was evaluated in mFSQ domains (Basic ADL, Intermediate ADL, Psychological Function, Quality of Interaction, Social Activity). In addition, correlation between Schwab & England ADL scale and observed mFSQ value across post-baseline visits were evaluated.
Results:
In total, 29 patients were enrolled in the study (mean age, 70.2 years; 62% males). All mFSQ domains demonstrated significant improvement at 16 weeks from baseline; however, the largest change was seen in Social Activity (n=18, LSM[SE]: 25.8 [7.52], p=0.0026). The correlation of mFSQ and the Schwab & England ADL scales resulted in a correlation coefficient of r=0.6 (p<.0001) for patient total score and r=0.5 (p<.0001) for caregiver total score.
Conclusions:
In this small study, treatment with pimavanserin was associated with improvement across all mFSQ domains; most improvement was seen in social activity. Additionally, the mFSQ was significantly correlated with the Schwab & England ADL; thus, this appears to be a promising scale deserving of further evaluation and use in clinical studies as well as in the clinic to complement other assessments.