Abstract
Objective: To develop, implement, and evaluate a model for the remote, long-term observation of Parkinson’s disease (PD) clinical trial cohorts. We will 1) establish and implement the infrastructure for a new remote research model 2) compare patient-driven versus clinician-driven outcomes and 3) explore novel smartphone-based real-life mobility biomarkers of PD disability and progression.
Background: STEADY-PD3 and SURE-PD3 are active NINDS-funded phase 3 interventional studies of potential disease-modifying therapeutics in PD. The long-term follow-up of clinical trial cohorts could provide valuable information on disease progression. The use of novel technologies and methods will enable frequent data collection, objective assessment in the home setting, and the development of novel digital biomarkers for future studies.
Design/Methods: In this 24-month observational study, we will enroll an estimated 420 participants from STEADY-PD3 and SURE-PD3 to prospectively and remotely characterize long-term clinical outcomes through the use of three platforms: tele-visits, smartphone-based assessments, and web-based surveys. Centralized movement disorders specialists will conduct annual tele-visits. Participants will complete two-week sessions of smartphone-based motor and cognitive tasks using mPower quarterly. For consented participants, mPower will passively collect GPS and accelerometer-based movement and activity data. Participants will be asked to enroll in a companion online study, Fox Insight, and to complete surveys quarterly. Data from the three platforms will be integrated with data from the parent studies and the complete dataset will be transferred to the Parkinson’s Disease Biomarkers Program’s Data Management Resource for use by the broader research community.
Results: AT-HOME PD was approved by the University of Rochester’s institutional review board on September 19th, 2018. Recruitment started October 2nd, 2018 and the first participant enrolled on October 8th, 2018.
Conclusions: We will use novel tele-health metrics to enable the remote, long-term follow-up of PD clinical trial cohorts and develop digital biomarkers of disease progression.
Disclosure: Dr. Schneider has received research support from Teva Pharmaceutical Industries; Nuredis, Inc; and Biohaven Pharma. Dr. Anthwal has nothing to disclose. Dr. Kayson has nothing to disclose. Dr. Omberg has nothing to disclose. Dr. Tarolli has nothing to disclose. Dr. Macklin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda Therapeutics, Shire Human Genetics Therapies, Biogen, Lavin Consulting LLC, Myolex Inc. Dr. Macklin has received research support from Acorda Therapeutics, Amylyx, GlaxoSmithKlein. Dr. Bataille has nothing to disclose. Dr. Dorsey has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with 23andMe, Abbott, Abbvie, American Well, Biogen, Clintrex, DeciBio, Denali Therapeutics, GlaxoSmithKline, Grand Rounds, Karger, Lundbeck, MC10, MedAvante, Medical-legal services, Mednick Associates, National Institute of Neurological Disorders and Stroke, Olson Research Group, Optio, Prilenia, Putnam Associates, Roche, Sanofi, Shire, Sunovion Pharma, Teva, UCB, Voyager Therapeutics. Dr. Dorsey has received personal compensation in an editorial capacity for Karger Publications. Dr. Dorsey has received research support from Abbvie, Acadia Pharmaceuticals, AMC Health, Biosensics, Burroughs Wellcome Fund, GlaxoSmithKline, Nuredis Pharmaceuticals, Pfizer, Prana Biotechnology, Raptor Pharmaceuticals, Roche, and Teva Pharmaceuticals. Dr. Mangravite has nothing to disclose. Dr. Schwarzschild has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prevail Therapeutics, Eli Lilly and Co., and Biotie/Acorda Therapeutics. Dr. Schwarzschild has received royalty, license fees, or contractual rights payments from MGH. Dr. Simuni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acadia, Adamas, Teva, UCB Pharma, Abbvie, Anavex, Allergan, Accorda, Neuroderm, Photopharmics, Revance, Sanofi, Sunovion, Voyager, US World Meds, and the Michael J. Fox Foundation. Dr. Simuni has received research support from Biogen, Roche, Neuroderm, Sanofi, NINDS, the Michael J. Fox Foundation, and the Parkinson Foundation.
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