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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
7U10NS044415-12
Application #
8704178
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2015-11-30
Budget Start
2013-07-01
Budget End
2013-11-30
Support Year
12
Fiscal Year
2013
Total Cost
$20,453
Indirect Cost
$7,508
Name
Rbhs-Robert Wood Johnson Medical School
Department
Neurology
Type
Schools of Medicine
DUNS #
078795875
City
Piscataway
State
NJ
Country
United States
Zip Code
08854
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
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
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
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
NINDS NET-PD Investigators (2008) A pilot clinical trial of creatine and minocycline in early Parkinson disease: 18-month results. Clin Neuropharmacol 31:141-50
Tilley, Barbara C; Galpern, Wendy R (2007) Screening potential therapies: lessons learned from new paradigms used in Parkinson disease. Stroke 38:800-3
Elm, Jordan J; Kamp, Cornelia; Tilley, Barbara C et al. (2007) Self-reported adherence versus pill count in Parkinson's disease: the NET-PD experience. Mov Disord 22:822-7
NINDS NET-PD Investigators (2007) A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology 68:20-8

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