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S4-001V2.0 Date: 26 February 2016 Page 1 of 53 Clinical Study Protocol

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S4-001V2.0 Date: 26 February 2016 Page 1 of 53 Clinical Study Protocol S4 Study Clinical Study Protocol Systemic Synuclein Sampling Study (S4) PROTOCOL NO.: S4-001 INVESTIGATIONAL PHASE: Observational PRINCIPAL/COORDINATING Danna Jennings, MD INVESTIGATOR: Senior Clinical Research Director Institute for Neurodegenerative Disorders 60 Temple Street, Suite 8B New Haven, CT 06510 203-401-4300 (phone) 203-401-4301 (fax) SPONSOR/FUNDING: The Michael J. Fox Foundation for Parkinson’s Research 498 Seventh Avenue, 18th Floor New York, NY 10018 212-509-0995 (phone) 212-509-2390 (fax) ORIGINAL VERSION DATE: Version 2.0.; Dated February 26, 2016 This clinical document is a confidential communication of The Michael J. Fox Foundation. The recipient agrees that no information contained herein will be published or disclosed without written approval. This document may be disclosed to appropriate institutional review boards, independent ethics committees, or duly authorized representatives of the U.S Food and Drug Administration, European Medicines Agency, or other regulatory authorities as appropriate; under the condition that confidentiality is requested. Protocol No.: S4-001v2.0 Date: 26 February 2016 Page 1 of 53 S4 Study CONTENTS CONTENTS .................................................................................................................. 2 STUDY CORE FACILITIES AND FACILITY CONTACT INFORMATION ......... 6 PROTOCOL APPROVAL SIGNATURES .................................................................. 7 INVESTIGATOR SIGNATURE PAGE ...................................................................... 8 LIST OF ABBREVIATIONS AND DEFINITIONS ................................................... 9 SYNOPSIS ................................................................................................................. 11 1. INTRODUCTION ............................................................................................... 15 1.1. Background ....................................................................................................... 15 1.2. Study Rationale ................................................................................................. 16 1.3. Ethical Rationale ............................................................................................... 18 2. STUDY OBJECTIVES ........................................................................................ 18 2.1. Primary Objective ............................................................................................. 18 2.2. Secondary Objectives ........................................................................................ 18 3. STUDY DESIGN................................................................................................. 19 3.1. Overall Study Design ........................................................................................ 19 3.2. Study Setting ..................................................................................................... 20 3.3. Study Population ............................................................................................... 20 3.3.1. Subject Numbers ............................................................................................ 20 3.3.2. Inclusion Criteria for PD Subjects ................................................................. 20 3.3.3. Inclusion Criteria for HC Subjects ................................................................. 21 3.3.4. Exclusion Criteria for all Subjects ................................................................. 21 3.3.5. Exclusion Criteria for PD Subjects ................................................................ 22 3.3.6. Exclusion Criteria for HC Subjects ................................................................ 22 3.3.7. Enrollment Monitoring for Age, Gender and Disease Stage ......................... 22 3.3.8. Exclusionary Medications .............................................................................. 23 3.4. Criteria for Termination of the Study ............................................................... 23 3.5. Replacement of Subjects ................................................................................... 23 4. INVESTIGATIONAL PLAN .............................................................................. 24 4.1. Subject Identification Numbers ........................................................................ 24 4.2. Schedule of Activities (See Appendix 1) .......................................................... 24 Protocol No.: S4-001v2.0 Date: 26 February 2016 Page 2 of 53 S4 Study 4.3. Study Procedures by Visit ................................................................................. 24 4.3.1. Screening Visit ............................................................................................... 24 4.3.2. Biofluid Collection and Skin Biopsy Visit .................................................... 25 4.3.3. Colon Tissue Collection Visit ........................................................................ 25 4.3.4. Submandibular Gland Tissue Collection Visit .............................................. 26 4.3.5. Follow-up Telephone Contacts ...................................................................... 26 4.3.6. Unscheduled Visits ........................................................................................ 27 5. STUDY PROCEDURES ..................................................................................... 27 5.1. Description of Study Assessments .................................................................... 27 5.1.1. Demographics ................................................................................................ 27 5.1.2. MDS-UPDRS ................................................................................................. 27 5.1.3. Hoehn and Yahr Stage ................................................................................... 28 5.1.4. Modified Schwab and England ...................................................................... 28 5.1.5. Scales for Outcomes in Parkinson’s Disease (SCOPA-AUT) ....................... 28 5.1.6. University of Pennsylvania Smell Identification Test (UPSIT) .................... 28 5.1.7. The Montreal Cognitive Assessment (MoCA) .............................................. 28 5.1.8. Dopamine Transporter Imaging ..................................................................... 29 5.1.9. Blood Sampling ............................................................................................. 30 5.1.10. Lumbar Puncture .......................................................................................... 30 5.1.11. Saliva Collection .......................................................................................... 30 5.1.12. Skin Biopsy .................................................................................................. 31 5.1.13. Colon Tissue Collection ............................................................................... 31 5.1.14. Submandibular Gland Tissue Collection ..................................................... 31 5.1.15. Safety Assessments ...................................................................................... 32 6. SAFETY REPORTING ....................................................................................... 33 6.1. Safety/Adverse Events ...................................................................................... 33 6.2. Adverse Event Definitions ................................................................................ 34 6.3. Serious Adverse Events .................................................................................... 36 6.4. Recording of Adverse Events ........................................................................... 36 6.5. Responsibilities for reporting Serious Adverse Events .................................... 37 7. REPORTABLE EVENTS ................................................................................... 37 Protocol No.: S4-001v2.0 Date: 26 February 2016 Page 3 of 53 S4 Study 8. REFERRALS FOR MEDICAL CARE ............................................................... 38 9. POTENTIAL RISKS ........................................................................................... 38 9.1. Blood Sampling ................................................................................................ 38 9.2. Lumbar Puncture ............................................................................................... 38 9.3. DaTSCAN™ SPECT Imaging ......................................................................... 38 9.4. Skin Biopsy ....................................................................................................... 39 9.5. Submandibular Gland Biopsy ........................................................................... 39 9.6. Flexible Sigmoidoscopy and Colon Biopsy ...................................................... 39 10. STATISTICAL METHODOLOGY .................................................................. 40 10.1. Analysis Populations ....................................................................................... 40 10.1.1. Safety Analysis Population: ......................................................................... 40 10.1.2. Synuclein Burden Population: ..................................................................... 40 10.2. Descriptive Statistics ....................................................................................... 40 10.3. Study Outcome Measures ..............................................................................
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