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Abstract Details

Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease Trials (AT-HOME PD): Initiation of a Long-Term Observational Study
Movement Disorders
P2 - Poster Session 2 (5:30 PM-6:30 PM)
10-011

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.

 

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.  
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. 
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. 
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.
Authors/Disclosures
Ruth Schneider, MD, FAAN (University of Rochester)
PRESENTER
Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Escape Bio. The institution of Dr. Schneider has received research support from The Michael J. Fox Foundation. The institution of Dr. Schneider has received research support from NIH. The institution of Dr. Schneider has received research support from Acadia Pharmaceuticals. The institution of Dr. Schneider has received research support from CHDI. The institution of Dr. Schneider has received research support from Biohaven Pharmaceuticals. The institution of Dr. Schneider has received research support from Parkinson Study Group. The institution of Dr. Schneider has received research support from The Michael J. Fox Foundation. The institution of Dr. Schneider has received research support from Bial. Dr. Schneider has received personal compensation in the range of $500-$4,999 for serving as a Telemedicine Evaluator with Parkinson's Foundation.
No disclosure on file
Elise P. Kayson, RN Elise Paulin Kayson, RN has nothing to disclose.
Larsson Omberg Larsson Omberg has nothing to disclose.
Christopher Tarolli, MD, FAAN (University of Rochester) Dr. Tarolli has received personal compensation for serving as an employee of University of Rochester. The institution of Dr. Tarolli has received research support from National Institutes of Health. The institution of Dr. Tarolli has received research support from Biogen. The institution of Dr. Tarolli has received research support from Neuron23. Dr. Tarolli has received personal compensation in the range of $500-$4,999 for serving as a Speaker, Committee Member with 好色先生. Dr. Tarolli has received personal compensation in the range of $500-$4,999 for serving as a Committee member with National Board of Medical Examiners. Dr. Tarolli has a non-compensated relationship as a Committee Member with 好色先生 that is relevant to AAN interests or activities.
Eric A. Macklin, PhD (Massachusetts General Hospital) The institution of Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AI Therapeutics. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Chase Therapeutics. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial Biotech. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson Healthcare LLC. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Macklin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Macklin has received research support from Biohaven. The institution of Dr. Macklin has received research support from Clene Nanomedicine. The institution of Dr. Macklin has received research support from Mitsubishi Tanabe Pharmaceuticals America. The institution of Dr. Macklin has received research support from Prilenia. The institution of Dr. Macklin has received research support from UCB Ra Pharma. The institution of Dr. Macklin has received research support from Revalesio. The institution of Dr. Macklin has received research support from Seelos. The institution of Dr. Macklin has received research support from Calico. The institution of Dr. Macklin has received research support from Denali. The institution of Dr. Macklin has received research support from NeuroDex. The institution of Dr. Macklin has received research support from Alector. The institution of Dr. Macklin has received research support from ITB-Med.
No disclosure on file
E. Ray Dorsey, MD, MBA (University of Rochester) Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seelos Therapeutics. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eden McCallum, LLP. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven Pharmaceuticals. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WebMD. Dr. Dorsey has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioSensics. Dr. Dorsey has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Mediflix. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevance. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kairos Cinema, LLC. Dr. Dorsey has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Mitsubishi Tanabe Pharma America Inc.. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Advarra. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medrhythms. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ANA. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for HMP 好色先生, LLP. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ADIVO Associates France. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for University of Toronto. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Philadelphia Neurological Society. Dr. Dorsey has stock in Included Health. Dr. Dorsey has stock in Mediflix. Dr. Dorsey has stock in SemCap. Dr. Dorsey has stock in Synapticure. The institution of Dr. Dorsey has received research support from NIH/NINDS. The institution of Dr. Dorsey has received research support from Burroughs Wellcome . The institution of Dr. Dorsey has received research support from Michael J. Fox Foundation - Fox Insight. The institution of Dr. Dorsey has received research support from Michael J. Fox Foundation - Emerald. The institution of Dr. Dorsey has received research support from B. Thomas Golisano Foundation. The institution of Dr. Dorsey has received research support from Emerald Innovations, Inc.. The institution of Dr. Dorsey has received research support from Photopharmics Inc.. The institution of Dr. Dorsey has received research support from Averitas Pharma Inc.. The institution of Dr. Dorsey has received research support from DOD/Army Medical Research Acquisition Activity. The institution of Dr. Dorsey has received research support from NIH/NINDS.
No disclosure on file
Michael Schwarzschild, MD, PhD (Massachusetts General Hospital) The institution of Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial Biotech (indirectly, as a service of the Parkinson Study Group service). The institution of Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen (indirectly, as a service of the Parkinson Study Group service). The institution of Dr. Schwarzschild has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB (indirectly, as a service of the Parkinson Study Group service). Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. The institution of Dr. Schwarzschild has received research support from NIH. The institution of Dr. Schwarzschild has received research support from Parkinson's Foundation. The institution of Dr. Schwarzschild has received research support from Michael J Fox Foundation. The institution of Dr. Schwarzschild has received research support from Farmer Family Foundation. Dr. Schwarzschild has a non-compensated relationship as a Chair, Executive Committee with the Parkinson Study Group that is relevant to AAN interests or activities.
Tanya Simuni, MD, FAAN (Northwestern University Feinberg School of Medicien) Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for cadia, AcureX, Adamas, AskBio, Amneal, Blue Rock Therapeutics, Caraway Therapeutics, Critical Path for Parkinson's Consortium (CPP), Denali, Michael J Fox Foundation, Neuroderm, Sanofi, Sinopia, Roche, Takeda and Vanqua Bio. Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for of Koneksa, Neuroderm, Sanofi, UCB, AcureX, Adamas, AskBio, Biohaven, Denali, GAIN, Neuron23 and Roche. Dr. Simuni has received research support from Amneal, Biogen, Neuroderm, Prevail, Roche, and UCB and an investigator for NINDS, MJFF, Parkinson's Foundation.