This application is in response to the Parkinson agenda for the NIH for the initiation of a randomized controlled clinical trial to test potential neuroprotectants in patients with early Parkinson's disease. The neuroprotectants to be tested in the trial have not yet been chosen and will be selected by an NINDS-appointed oversight committee. It is expected that NIH will fund 42 Parkinson's Disease Neuroprotection Clinical Centers to the institutions who demonstrate the ability to recruit subjects and provide high quality data for the trial(s). This application describes the characteristics of the staff and Parkinson's disease clinical center at Scott & White Clinic/Texas A & M College of Medicine that will be able to fulfill these goals. The following specific aims will be met subject to final common protocol finalized by the NINDS-appointed oversight committee. 1). Recruit 12 or more patients in the early stages of Parkinson's disease for the pilot study. 2). Recruit 72 or more patients for the main study once the final neuroprotectant is chosen from the initial pilot studies. The above patients will be in the early, mild Parkinson's disease, not yet requiring symptomatic treatment and unexposed to prior treatment with levodopa/dopamine agonist/selegiline (within four months). 3). For primary outcome measure to assess the degree of Parkinson's disease, and its progression the Unified Parkinson's Disease Rating Scale (UPDRS) (or one selected by NINDS-appointed oversight committee) will be followed for a highly reliable functional outcome or disability scale that is multi-modal in each subject and other protocols that may be implemented with the subject and investigator remaining """"""""blinded"""""""" as to treatment assignment through the duration of the study. 4). For secondary outcome measures, monitor any adverse events from medication(s), quality of life measurement, depression, dementia and others by use of appropriate scales included in the final common protocol (such as Adverse Reaction Form, Hamilton Depression Scale and Mini-Mental State Exam) over the duration of the study. The PI has a proven track record in having participated in a large number of clinical trials involving early Parkinson's disease patients, has been involved in drug development for Parkinson's disease and has a team of well qualified staff, with access to large number of early Parkinson's disease patients including women and minority patients, through a network of a large primary care physicians along with a long-term track record of involvement in both laboratory and clinical care in the treatment of Parkinson's disease. Thus, the investigators have adequate experience, resources, and proven ability to recruit suitable early Parkinson's disease subjects and carry out the clinical trial to meet the requirements of RFA-NS-02-010 in a timely manner.
