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Abstract Details

Modeling PD Progression in the PPMI Cohort: Implications for Clinical Trial Design
Movement Disorders
P10 - Poster Session 10 (5:30 PM-6:30 PM)
3-002
We used Parkinson Progression Marker Initiative (PPMI) data to assess the frequency of progression to clinically meaningful disease milestones and examine baseline predictors of reaching these milestones.
To date, several different ways of defining progression for Parkinson’s disease have been proposed based on motor, cognitive, or imaging outcomes. If examined over time, there is little concordance across these different outcomes, likely due to disease heterogeneity. Thus, a challenge for future PD research is to develop more efficient endpoints that can account for this disease heterogeneity.
We measured milestones across six domains – “Walking & Balance”, “Motor Complications”, “Cognition”, “Autonomic”, “Schwab & England”, & “Motor Function”. First, we explored whether metrics within any of the above criteria were met at any visit. Second, we applied a more rigid definition of whether criteria were met at consecutive visits. We then conducted a time-to-event analysis to explore whether baseline factors including: demographic factors, clinical features of PD and CSF and imaging biomarkers were associated with progression.
The cognitive domain was the most commonly reached outcome, with 41% and 62% of eligible subjects meeting criteria at any visit and at consecutive visits, respectively. The functional independence and autonomic domains were the next highest. Increasing age, MDS-UPDRS total score, GDS and decreasing mean striatum SBR predicted progression in both models.  Worse RBD symptoms were a significant predictor for meeting any domain at a single visit. Decreasing CSF abeta and increasing p-tau were significant predictors for the model examining the outcome requiring meeting domains at consecutive visits.

Clinically relevant milestones occur frequently within 5 years of follow-up of patients recruited with early, untreated PD, and are significantly associated with certain baseline clinical features and biomarkers.  Stratification based on such markers may reduce heterogeneity in clinical trial cohorts and make trials more efficient. 

Authors/Disclosures
Christopher Coffey, PhD, FÂ鶹´«Ã½Ó³»­ (University of Iowa)
PRESENTER 		Dr. Coffey has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Heart Association. The institution of Dr. Coffey has received research support from NIH. The institution of Dr. Coffey has received research support from Michael J Fox Foundation.
Michael Brumm No disclosure on file
Andrew D. Siderowf, MD Dr. Siderowf has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boehringer-Ingelheim. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for askbio. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for capsida. Dr. Siderowf has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Parkinson Study Group. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theravance. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Prilenia. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Wave. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurogastrix. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Prevail. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alerity. Dr. Siderowf has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Clintrex. Dr. Siderowf has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. Dr. Siderowf has a non-compensated relationship as a Scientific Advisory Board with NeuroPacs that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Tanya Simuni, MD, FÂ鶹´«Ã½Ó³»­ (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.
Douglas Galasko, MD (Dept. of Neurosciences, UCSD) Dr. Galasko has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. Dr. Galasko has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly, Inc. Dr. Galasko has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Diagnostics. Dr. Galasko has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cognition THeraprutics. Dr. Galasko has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Artery Therapeutics.
Brit Mollenhauer No disclosure on file
Lana Chahine, MD, FÂ鶹´«Ã½Ó³»­ Dr. Chahine has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gray Matters Technology. The institution of Dr. Chahine has received research support from UPMC. The institution of Dr. Chahine has received research support from MJFF. The institution of Dr. Chahine has received research support from Denali/Biogen. Dr. Chahine has received publishing royalties from a publication relating to health care.
Vanessa Arnedo, MPH No disclosure on file
Mark Frasier No disclosure on file
Caroline M. Tanner, MD, PhD, FÂ鶹´«Ã½Ó³»­ (University of California San Francisco, Weill Institute for Neurosciences) Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Evidera. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals/Cavion. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial . Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche Genentech. The institution of Dr. Tanner has received research support from Gateway LLC. The institution of Dr. Tanner has received research support from Roche\Genentech. The institution of Dr. Tanner has received research support from Michael J Fox Foundation . The institution of Dr. Tanner has received research support from National Institute of Health . The institution of Dr. Tanner has received research support from Department of Defense. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Faculty, CME presentation with Medscape /WebND.
Kathleen Poston, MD, FÂ鶹´«Ã½Ó³»­ (Stanford University) Dr. Poston has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Curasen Therapeutics, INC. Dr. Poston has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Amprion, INC. Dr. Poston has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NIH. Dr. Poston has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorders Journal. Dr. Poston has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of Neurology. Dr. Poston has stock in Curasen Therapeutics, INC. Dr. Poston has stock in Amprion, INC. The institution of Dr. Poston has received research support from NIH. The institution of Dr. Poston has received research support from Michael J Fox Foundation. The institution of Dr. Poston has received research support from Alzheimer's Drug Discovery Foundation . The institution of Dr. Poston has received research support from Lewy Body Dementia Association. Dr. Poston has received intellectual property interests from a discovery or technology relating to health care.
Daniel Weintraub Daniel Weintraub has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clintrex. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Daniel Weintraub has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Modality.ai. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CuraSen. Daniel Weintraub has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boehringer Ingelheim. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Daniel Weintraub has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia. Daniel Weintraub has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorder Society. The institution of Daniel Weintraub has received research support from NIH. The institution of Daniel Weintraub has received research support from Fox Foundation. The institution of Daniel Weintraub has received research support from IPMDS. Daniel Weintraub has received intellectual property interests from a discovery or technology relating to health care.
No disclosure on file
Karl D. Kieburtz, MD (University of Rochester Medical Center) Dr. Kieburtz has received personal compensation for serving as an employee of Clintrex Research Corporation. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Kieburtz has stock in Clintrex Research Corp. Dr. Kieburtz has stock in Hoover Brown. An immediate family member of Dr. Kieburtz has stock in Hoover Brown. Dr. Kieburtz has stock in Safe Therapeutics. The institution of Dr. Kieburtz has received research support from NIH. The institution of Dr. Kieburtz has received research support from Michae J Fox Foundation.
Kenneth L. Marek, MD (IND) Dr. Marek has received personal compensation for serving as an employee of IND. Dr. Marek has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for invicro. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for takeda. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Denali. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Koneksa. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xingimaging. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuron23. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Marek has received research support from Michael J Fox Foundation.
No disclosure on file