The Michael J. Fox Foundation/The International Society for CNS Clinical Trials and Methodology (ISCTM)

Day 1 (21 February 2007)

MJFox Foundation Satellite Meeting Summary
Welcome and Meeting Goals	K Kieburtz R Anand
What is Parkinson’s Disease?	JW Langston
Background on Parkinson’s Disease and Neuroprotective Treatment	A Lang
Neuroprotection Trial Designs and Underlying Assumptions – When Can They Best Be Applied to Effectively Measure Neuroprotection The Mystique of Neuroprotection for Parkinson’s Disease	W Olanow I Shoulson
The Selection of Patient Groups for Neuroprotective Trials	W Poewe
Identifying Endpoints For Effectively Measuring Neuroprotection	C Tanner
Non-Clinical Endpoints to Assess Disease Progression Neuroimaging of disease progression Biomarker Measures	J Perlmutter B Ravina

Introduction	K Kieburtz
Statistical Issues in Early Phase Studies	B Levin
An Industry Perspective on Neuroprotective Trials	B Musch
Neurodegenerative Disorder Therapeutics – Process and Product Amid Complexity How to view the concept of neuroprotection? What is necessary to ensure interpretable outcomes? How and where might neuroprotection fit into a drug label? Issues of delayed-start or other designs and potential labeling	M Walton
European Regulatory Perspective on the Concept of Disease Modification in Parkinson’s Disease	J Ferreira
Summary & Next Steps	K Kieburtz