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Clinical Research

• Neuroprotective Agents for Clinical Trials
  
  The information presented on this web site is a summary of data gathered evaluating potential neuroprotective agents for clinical trials in treating Parkinson's Disease (PD). Treatments that are currently used for PD reduce symptoms but become less effective over time, as the underlying disease progresses. Thus, the identification of therapies that can slow or stop the progression of PD would be of tremendous benefit. NINDS has committed to a series of studies to evaluate potential neuroprotective agents in treating PD. A team of pharmacologists, clinicians, and clinical trial experts - including NINDS staff - developed specific criteria for the evaluation of potential therapies, including scientific rationale, blood-brain barrier penetration, safety and tolerability, and evidence of efficacy in animal models or humans. This team, called the Committee to Identify Neuroprotective Agents in Parkinson's (CINAPS), solicited suggestions from scientists and clinicians in academia and industry, as well as patient and foundation groups, in order to identify as many potential therapies as possible.
  
  
• Minimum Data Set
  
  NINDS sponsored a Clinical Criteria meeting of outside researchers and NIH staff to discuss development of a minimum data set for both clinical diagnosis and pathological diagnosis of PD that can be used to improve the accuracy of collecting PD tissues. Working groups assigned at the meeting have completed a minimum clinical and pathological data set for use in developing future grant solicitations that include the collection of PD tissues by coordinated research centers. This document will be evaluated and updated as necessary.
  
  
  • Parkinsonism Clinical Data
    
    
  • Diagnosis of Pathology
  
  
  
• Neuroprotection Trials in Parkinson's
  
  No drug has been shown convincingly to slow the progression of Parkinson's disease. Efficacious neuroprotective agents (i.e. disease-modifying drugs) could importantly impact neurological disability for hundreds of thousands of Americans with this disorder. The design of future randomized clinical trials of neuroprotective drugs optimally should be planned with awareness of the previous trials undertaken with the same goal, to profit from their experience. Here, all randomized clinical trials in humans testing putative neuroprotective drugs in Parkinson's disease are identified that have been previously published or about which information is publicly available, and their key design features summarized.
  
  

Last updated August 13, 2008