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Abstract Details

Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results
P10 - Poster Session 10
There is limited prospective, real-world data describing the changing clinical outcomes and disease burden for patients with PD. 
Describe the long-term clinical outcomes and disease burden of Parkinson’s disease (PD) in patients with motor fluctuations inadequately controlled by current medications.
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).

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.

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.

Authors/Disclosures
Pavnit Kukreja, PharmD (AbbVie)
PRESENTER
Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Victor Fung, MD, PhD, MBBS Dr. Fung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Fung has received publishing royalties from a publication relating to health care.
Kazuko Hasegawa, MD (Dept Neurology, Sagamihara Natl Hospital) Dr. Hasegawa has nothing to disclose.
Alberto J. Espay, MD, FAAN (University of Cincinnati) Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus (formerly, USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avion Pharmaceuticals. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Pilar Sanchez Alonso Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving as a Consultant for zambon. Pilar Sanchez Alonso has received personal compensation in the range of $0-$499 for serving as a Consultant for Bial. Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for zambon. The institution of Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for abbvie. Pilar Sanchez Alonso has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for zambon. Pilar Sanchez Alonso has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for bial. Pilar Sanchez Alonso has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for novartis.
Ramsey A. Falconer, MD (Inova Parkinson's & Movement Disorders Center) Dr. Falconer has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbott. Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Falconer has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Amneal. Dr. Falconer has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for GE Health. Dr. Falconer has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Acorda. Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. Dr. Falconer has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Federal Trade Comission (FTC). Dr. Falconer has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Justice Department.
Jorge Zamudio, MD, MBA (Abbvie) Dr. Zamudio has received personal compensation for serving as an employee of Abbvie. Dr. Zamudio has received personal compensation for serving as an employee of Abbvie. Dr. Zamudio has received stock or an ownership interest from Abbvie .
Koray Onuk Koray Onuk has nothing to disclose.
Meredith Hatcher, PA (Texas Movement Disorder Specialists) Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal. Mrs. Hatcher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie.
Connie H. Yan, PhD, PharmD (AbbVie Inc) Dr. Yan has nothing to disclose.
Carrie Ferguson (AbbVie) Ms. Ferguson has received personal compensation for serving as an employee of AbbVie. Ms. Ferguson has stock in AbbVie.