Abstract Details

Title Use of the Modified Functional Status Questionnaire to Assess Functioning in Patients with Parkinson’s Disease Psychosis Treated with Pimavanserin

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-005

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.

Authors/Disclosures
Greg Remigio, PhD (ACADIA Pharmaceuticals) PRESENTER	Dr. Remigio has received personal compensation for serving as an employee of Acadia Pharmaceuticals. An immediate family member of Dr. Remigio has received personal compensation for serving as an employee of ICON PLC. An immediate family member of Dr. Remigio has received personal compensation for serving as an employee of Daiichi Sankyo. Dr. Remigio has stock in Acadia Pharmaceuticals.
Nazia Rashid (acadia pharmacetuicals)	Nazia Rashid has received personal compensation for serving as an employee of Acadia Pharmaceuticals.
Lambros Chrones, MD	Dr. Chrones has received personal compensation for serving as an employee of Acadia Pharmaceuticals.
Ratna Revankar	No disclosure on file
Dilesh Doshi, PharmD (Acadia)	Dr. Doshi has received personal compensation for serving as an employee of Acadia Pharmaceuticals.
Victor Abler, DO (Acadia Pharmaceuticals)	Dr. Abler has stock in Acadia Pharmaceuticals .
Virgilio Gerald H. Evidente, MD, FAAN (Movement Disorders Center of Arizona)	Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Evidente has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Evidente has received research support from CND. The institution of Dr. Evidente has received research support from Aeon. The institution of Dr. Evidente has received research support from Bukwang Pharmaceuticals. The institution of Dr. Evidente has received research support from Jazz Pharmaceuticals. The institution of Dr. Evidente has received research support from Scion Neurostim. The institution of Dr. Evidente has received research support from Theravance Biopharma. Dr. Evidente has received research support from Cerevance. Dr. Evidente has received research support from Ipsen.

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