Specific Aim 1: To participate as a clinical center in the National Institute of Neurological Disorders and Stroke (NINDS) Parkinson Disease Neuroprotection clinical trial.The University of South Florida Parkinson's Disease and Movement Disorders Center and affiliated clinics will enroll at least 84 subjects with early Parkinson's disease over 3 1/2 years as part of the NINDS simple neuroprotection trial. The clinical trial will be conducted at the University of South Florida's Parkinson's disease and Movement Disorders Center, a very active clinical care and clinical research facility located in Harbourside Medical Tower adjacent to Tampa General Hospital. Subjects will be recruited from this center and affiliated clinics. These include 1) James A. Haley VA Parkinson's disease and Movement Disorders Center, 2) The University of South Florida Medical clinics and 3) The University of South Florida/Tampa General Hospital Indigent Care Neurology Clinic. The center has a proven track record and reputation as a high quality and high enrollment clinical trials site in Parkinson's disease and other movement disorders. Over 54 clinical trials have been conducted at the center since its inception and 43 over the last 5 years. Over the last 5 years, 256 Parkinson's disease patients have been entered in these clinical trials and 104 Parkinson's disease patients with early Parkinson's disease have been entered in the clinical trials.Participating physicians will include Robert A. Hauser, M.D., Thresa A. Zesiewicz, M.D., and Juan Sanchez-Ramos, M.D. Lisa Gauger will serve as administrator and Roberta Henneman will serve as study coordinator.
Specific Aim II : To participate in the development of the design of the neuroprotection trial.
Specific Aim III : To participate in the selection of possible neuroprotective agents to be studied.
|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|