A major goal of the neuroscience community is to develop neuroprotective treatments that will slow or forestall the progression of chronic neurodegenerative diseases. Recent advances in the understanding of the pathogenesis of Parkinson's disease (PD),including the development of relevant animal models, provide the opportunity for rationale clinical trials to assess neuroprotective treatments. This application proposes an academically based clinical trials coordination center to finalize study protocols, train clinical centers, receive and manage all clinical trial data, maintain quality and regulatory standards, and organize packaging and delivery of experimental treatments to clinical centers. This Coordination Center will maintain an administrative structure that fosters close collaboration among, the Statistical center, clinical centers, NINDS Scientific Program personnel and an NIH Oversight Committee. Additional proposals include a rational process to select potential neuroprotective agents that will maximize the likelihood of successful choices, designs for pilot safety tolerability and dosage ranging studies, and the design for a large simple clinical trial to assess the impact of interventions on PD progression. The new onset of postural instability, one of the cardinal clinical signs of PD and a robust predictor of morbidity and mortality, is proposed as the primary clinical measure of disease progression. In addition to being a core clinical feature of PD and being reliably measurable, postural instability is inherently resistant to short-term symptomatic amelioration by current PD medications. Three potential neuroprotective compounds are proposed, although the final selection of compounds will be based on deliberations with other investigators. An appropriate research infrastructure combined with relevant scientific expertise is in place to conduct the proposed studies of neuroprotective agents in PD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS043128-10
Application #
7989392
Study Section
Special Emphasis Panel (ZNS1-SRB-P (02))
Program Officer
Moy, Claudia S
Project Start
2001-09-30
Project End
2012-11-30
Budget Start
2010-12-01
Budget End
2012-11-30
Support Year
10
Fiscal Year
2011
Total Cost
$2,321,905
Indirect Cost
Name
University of Rochester
Department
Neurology
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
Yang, Chengwu; Vrana, Kent E (2018) Rescuing Suboptimal Patient-Reported Outcome Instrument Data in Clinical Trials: A New Strategy. Healthcare (Basel) 6:
Luthra, Nijee S; Kim, Soeun; Zhang, Yunxi et al. (2018) Characterization of vitamin D supplementation and clinical outcomes in a large cohort of early Parkinson's disease. J Clin Mov Disord 5:7
Gibbons, Christopher H; Simon, David K; Huang, Meilin et al. (2017) Autonomic and electrocardiographic findings in Parkinson's disease. Auton Neurosci 205:93-98
Wills, Anne-Marie; Li, Ruosha; Pérez, Adriana et al. (2017) Predictors of weight loss in early treated Parkinson's disease from the NET-PD LS-1 cohort. J Neurol 264:1746-1753
Chou, Kelvin L; Elm, Jordan J; Wielinski, Catherine L et al. (2017) Factors associated with falling in early, treated Parkinson's disease: The NET-PD LS1 cohort. J Neurol Sci 377:137-143
Luo, Sheng; Chan, Wenyaw; Detry, Michelle A et al. (2016) Binomial regression with a misclassified covariate and outcome. Stat Methods Med Res 25:101-17
He, Bo; Luo, Sheng (2016) Joint modeling of multivariate longitudinal measurements and survival data with applications to Parkinson's disease. Stat Methods Med Res 25:1346-58
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
Luo, Sheng; Lawson, Andrew B; He, Bo et al. (2016) Bayesian multiple imputation for missing multivariate longitudinal data from a Parkinson's disease clinical trial. Stat Methods Med Res 25:821-37
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

Showing the most recent 10 out of 49 publications