Abstract

This application, in response to a request from the Neurodegeneration and Clinical Trials Groups of the NINDS, provides data in support of our ability to become a clinical center to collaborate in the performance of a large, double-blind randomized trial of two or more potential neuroprotective agents in patients early in the course of Parkinson's disease. Our group has been conducting clinical trials in Parkinson's disease patients since 1983. We have a large patient population and a wide referral network. Administrative and coordinating systems necessary for the successful completion of such a trial are already in place and working. We have a record of adhering to similar common protocols and cooperating with other centers and will do so for this trial.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
4U10NS044415-06
Application #
7566164
Study Section
Special Emphasis Panel (ZNS1-SRB-L (01))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2012-11-30
Budget Start
2008-04-01
Budget End
2008-11-30
Support Year
6
Fiscal Year
2008
Total Cost
$47,759
Indirect Cost

  Institution

Name
University of Medicine & Dentistry of NJ
Department
Neurology
Type
Schools of Medicine
DUNS #
617022384
City
Piscataway
State
NJ
Country
United States
Zip Code
08854

  Publications

Yang, Chengwu; Vrana, Kent E (2018) Rescuing Suboptimal Patient-Reported Outcome Instrument Data in Clinical Trials: A New Strategy. Healthcare (Basel) 6:
Wills, Anne-Marie A; Elm, Jordan J; Ye, Rong et al. (2016) Cognitive function in 1736 participants in NINDS Exploratory Trials in PD Long-term Study-1. Parkinsonism Relat Disord 33:127-133
Wills, Anne-Marie A; Pérez, Adriana; Wang, Jue et al. (2016) Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1 JAMA Neurol 73:321-8
Elm, Jordan J; NINDS NET-PD Investigators (2012) Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1. Mov Disord 27:1513-21
Tilley, Barbara C; Mainous 3rd, Arch G; Elm, Jordan J et al. (2012) A randomized recruitment intervention trial in Parkinson's disease to increase participant diversity: early stopping for lack of efficacy. Clin Trials 9:188-97
Elble, Rodger J; Suchowersky, Oksana; Shaftman, Stephanie et al. (2010) Impact of belief in neuroprotection on therapeutic intervention in Parkinson's disease. Mov Disord 25:1082-6
Schneider, Jay S; Elm, Jordan J; Parashos, Sotirios A et al. (2010) Predictors of cognitive outcomes in early Parkinson disease patients: The National Institutes of Health Exploratory Trials in Parkinson Disease (NET-PD) experience. Parkinsonism Relat Disord 16:507-12
Evatt, Marian L; Chaudhuri, K Ray; Chou, Kelvin L et al. (2009) Dysautonomia rating scales in Parkinson's disease: sialorrhea, dysphagia, and constipation--critique and recommendations by movement disorders task force on rating scales for Parkinson's disease. Mov Disord 24:635-46
Yang, Chengwu; Garrett-Mayer, Elizabeth; Schneider, Jay S et al. (2009) Repeatable battery for assessment of neuropsychological status in early Parkinson's disease. Mov Disord 24:1453-60
Mauldin, Patrick D; Guimaraes, Paulo; Albin, Roger L et al. (2008) Optimal frequency for measuring health care resource utilization in Parkinson's disease using participant recall: the FS-TOO resource utilization substudy. Clin Ther 30:1553-7

Showing the most recent 10 out of 15 publications