Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results
Alberto Espay1, Pilar Sanchez Alonso2, Ramsey Falconer3, Carrie Ferguson4, Kazuko Hasegawa5, Meredith Hatcher6, Pavnit Kukreja4, Koray Onuk4, Connie Yan4, Jorge Zamudio4, Victor Fung7
1University of Cincinnati, 2Department of Neurology, Movement Disorders Unit, Hospital Puerta de Hierro Majadahonda, 3Inova Parkinson's and Movement Disorders Center, 4AbbVie, 5Dept Neurology, Sagamihara Natl Hospital, 6Texas Movement Disorder Specialists, 7Westmead Hospital & Sydney Medical School, University of Sydney
Objective:
Describe the long-term clinical outcomes and disease burden of Parkinson’s disease (PD) in patients with motor fluctuations inadequately controlled by current medications.
Background:
There is limited prospective, real-world data describing the changing clinical outcomes and disease burden for patients with PD.
Design/Methods:
PROSPECT is a 24-month prospective, observational, international study evaluating the progression and disease burden of patients with PD inadequately controlled by oral conventional therapy (and potentially eligible for device-aided treatments). Key eligibility criteria include patients aged ≥ 30 years inadequately controlled after optimization efforts with available oral medication, and ≥ 2.5 hours of “Off” time/day. The primary endpoint is change in “Off” time from baseline to 24 months assessed by the patients’ PD diary. Other assessments include disease severity (H&Y “On” state), changes in non-motor symptoms (NMS scale [NMSS] and PD Sleep Scale-2 [PDSS-2]), activities of daily living (UPDRS II), quality of life (PD Questionnaire-39 [PDQ-39] and EQ-5D-5L), cognitive function (Mini-Mental State Evaluation), health care resource utilization, caregiver burden (Modified Caregiver Strain Index), treatment satisfaction (TSQM-9) and patient global impression of change in severity (PGIC-S).
Results:
This analysis of baseline demographics and disease characteristics included 232 patients from 7 countries including the US (52.6% male, 72% white, mean age of 67.9 ± 9.4 years, and PD duration of 9.1 ± 5.5 years). At baseline, the mean ± SD Off time (hours/day), H&Y stage, NMSS total score, and PDQ-39 summary index were 5 ± 2.5, 2.2 ± 0.8, 43.4 ± 30.6, and 23.7 ± 14.3, respectively.
Conclusions:
The study is ongoing, and results will provide real-world, long-term prospective insights on the progression of disease burden, clinical outcomes, and treatment patterns in patients with PD.