This application is in response to RFA-NS-05-004 entitled """"""""Parkinson Disease Neuroprotection Clinical Trial: Clinical Centers."""""""" The specific aim is to collaborate, as a clinical center, in clinical trials to test potential neuroprotective agents in patients with Parkinson's disease. This is a timely and exciting initiative as, despite the availability of increasingly sophisticated medical and surgical treatments to alleviate many of its symptoms, no treatment has, to date, been definitively proven to slow or arrest the progression of Parkinson's disease. As director of the Movement Disorders Section of the Department of Neurology at LSU Health Sciences Center - Shreveport, serving as a medical hub for a region that includes northern and central LA, northeast TX, and southwestern AR with well over 500,000 people, the PI actively follows 333 patients with a diagnosis of Parkinson's disease in private office, hospital-based, and VA clinics. He has established local and regional support groups, comprehensive rehabilitation programs, and a privately funded resource center for patients that also serve as a source of pilot funding for Parkinson's-related research. As investigator and coordinator members of the Parkinson Study Group (PSG), the PI and this study's designated nurse coordinator are currently participating in a PSG sponsored trial of a medication for early, untreated, Parkinson's disease. Eleven patients were randomized for this study in under 16 months; all of these patients have remained in this study (last patient enrolled 1/04), with strict protocol adherence maintained. The PI is currently participating in an additional double-blind study for more advanced patients, and in an open-label study of the same medication. In previous trials with this and other medications, enrollment goals were typically achieved. The PI should have no difficulty in recruiting one or more de novo participants per month for pilot trials, and up to 2 or more per month during the phase 3 trial that will include patients recently started on symptomatic therapy. Support for this study has been offered by the Department, by neurologists in the community and local VA, by the Parkinson Association of LA, and by regional support groups. An afternoon clinic will be set aside for evaluating newly referred patients, including minorities and women, who might be candidates for this study. A secretary dedicated full-time to Parkinson's activities will assist with recruitment and a student worker will assist with data management. ? ?
|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|