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Outlines sponsor/funder and investigator roles and provides a comprehensive list of abbreviations and related study terminology.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/research-report/","Research & Report",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/the-mjff-lite-study-protocol-us-protocol-approval-27/290469/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/the-mjff-lite-study-protocol-us-protocol-approval-27/290469.png","ImageObject",300,407,{"name":42,"@type":43},"Mali","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-23","2026-09-17",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",10,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the primary objective of the LITE study?","Question",{"text":63,"@type":64},"To identify critical biological markers for LRRK2-driven Parkinson’s disease.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What study design and study duration are specified?",{"text":68,"@type":64},"The study uses a cross-sectional, observational design, with a planned study period of 2 years and clinical phase duration up to 30 days.",{"name":70,"@type":61,"acceptedAnswer":71},"Who serves as the U.S. principal investigator and what is their role?",{"text":72,"@type":64},"Thomas Tropea, DO serves as the U.S. Principal Investigator (PI). The PI is responsible for conducting the study within the U.S., with site investigators overseeing conduct at their respective sites under PI oversight.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},290469,1789641752,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,111,115,120,123,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":108,"show_sort_weight":109,"slug":110},7,"Healthcare",40,"healthcare",{"id":112,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":113,"slug":114},8,30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":55,"slug":125},"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":112,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":139,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":80,"read_time":144,"preview_page_count":4},2336475104362,"https://ap-avatar.wpscdn.com/avatar/22000c4c46a41b752dd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786595829695023868","Docusign Envelope ID: 1E45AA16-4DA9-47C4-BAF5-7B7C4E9FF776   \nTHE MJFF LITE STUDY PROTOCOL  \nTitle:  \nThe MJFF LRRK2 Investigative Therapeutics Exchange (LITE) Study  \nThe LITE Study  \nFunder:  \nThe Michael J. Fox Foundation for Parkinson’s Research (MJFF)  \nGlobal Study Lead:  \nEsther Sammler, MD PhD  \nU.S. Sponsor:  \nInstitute for Neurodegenerative Disorders (IND)  \nU.S. Principal Investigator:  \nThomas FTropea, DO  \nU.S. Site Investigators:  \nEthan Brown, MD and Neha Prakash, MBBS  \nStudy research numbers:  \nU.S. Protocol ID: 027  \nU.S. PROTOCOL APPROVAL  \nThe undersigned confirm that the following protocol has been agreed and approved by the Sponsor and that the Principal and Site Investigators agree to conduct the study in compliance with this approved protocol and will adhere to the principles of GCP, the SOPs, and any other applicable regulatory requirements as may be amended from time to time.  \nThomas Tropea, DO  \nU.S. Principal Investigator  \nSignature  \n8/26/2025  \nDate  \nDocusign Envelope ID: 1E45AA16-4DA9-47C4-BAF5-7B7C4E9FF776   \nSUMMARY  \n\n| Study Title | The MJFF LRRK2 Investigative Therapeutics Exchange (LITE) Study\u003Cbr>The LITE Study |\n| --- | --- |\n| Study Design | Cross-sectional, observational |\n| Study Population | Parkinson’s Disease including genetic (monogenic) and Non-genetic (idiopathic) Parkinson’s Disease\u003Cbr>Non-Parkinson’s Disease |\n| Sample Size | Global: 1000\u003Cbr>U.S.: 200 |\n| Planned study period | 2 years |\n| Clinical phase duration | Up to 30 days |\n| Primary | Objective\u003Cbr>To identify critical biological markers for LRRK2-driven Parkinson’s Disease |\n\nROLE OF TRIAL SPONSOR AND FUNDER-US  \nThe Sponsor of the LITE study within the United States (U.S.) is The Institute for Neurodegenerative Disorders (IND) .  \nThe roles and responsibilities of the Sponsor and Funder will be detailed in the Clinical Research Agreement.  \nROLES & RESPONSIBILITIES OF STUDY MANAGEMENT COMMITTEES/GROUPS & INDIVIDUALS–  \nU.S.  \nThe U.S. Principal Investigator (PI) will be responsible for the conduct of the study within the U.S. The U.S. Site Investigators (SI) will be responsible for the conduct of the study at their respective site and be overseen by the U.S. PI. A study-specific Site Delegation Log will be prepared by the U.S. sites detailing the duties of each member of staff working on the study.  \nThe study will be conducted in accordance with the principles of Good Clinical Practice (GCP) .  \nDocusign Envelope ID: 1E45AA16-4DA9-47C4-BAF5-7B7C4E9FF776   \nLIST OF ABBREVIATIONS  \nAE  \nASAP  \nαSyn  \nαSyn-SAA  \nCI  \nCRO  \nCSF  \nCTSDMC  \nDaT imaging  \nDNA  \nDRIG  \neCRF  \nEDC  \nFDA  \nGBA  \nGCP  \nGE  \nGP2  \nHIPAA  \nICF  \nID  \nIND  \nIP  \nIRB  \nISF  \nIU  \nLITE  \nLONI  \nLRRK2  \nLRRK2-PD  \nMDS  \nUPDRS  \nAdverse Event  \nAligning Science Across Parkinson’s Alpha-synuclein  \nAlpha-synuclein seed amplification assay Chief Investigator  \nContract Research Organizations Cerebrospinal fluid  \nClinical Trials Statistical and Data Management Center Dopamine Transporter scan  \nDeoxyribonucleic Acid  \nDundee Parkinson’s UK Research Interest Group Electronic Case Report Form  \nElectronic Data Capture Food and Drug Administration Glucocerebrosidase  \nGood Clinical Practice General Electric  \nGlobal Parkinson’s Genetics Program  \nHealth Insurance Portability and Accountability Act Informed Consent Form  \nIdentification  \nInstitute for Neurodegenerative Disorders Investigational Product  \nInstitutional Review Board Investigator Site File Indiana University  \nLRRK2 Investigative Therapeutics Exchange The Laboratory of Neuro Imaging  \nLeucine-rich repeat kinase 2  \nLeucine-rich repeat kinase 2-Parkinson’s disease  \nMovement Disorder Society revision of the Unified Parkinson’s Rating Scale  \nDisease  \nDocusign Envelope ID: 1E45AA16-4DA9-47C4-BAF5-7B7C4E9FF776   \nMERQ-PD Extended Mini Environmental Risk Questionnaire for Parkinson's Disease  \nMJFF The Michael J. Fox Foundation for Parkinson’s Research  \nmL Microliter  \nMoCA Montreal Cognitive ","cbCaitmTpjhpbcmf","https://ap.wps.com/l/cbCaitmTpjhpbcmf","pdf",1063003,31,"English","# SUMMARY\n# ROLE OF TRIAL SPONSOR AND FUNDER-US\n# ROLES & RESPONSIBILITIES OF STUDY MANAGEMENT COMMITTEES/GROUPS & INDIVIDUALS– U.S.\n# LIST OF ABBREVIATIONS\n# TABLE OF CONTENTS\n## PROTOCOL\n## BACKGROUND\n### INTRODUCTION TO THE MJFF LRRK2 INVESTIGATIVE THERAPEUTICS EXCHANGE (LITE) INITIATIVE\n### PARKINSON’S DISEASE\n### PARKINSON’S DISEASE AND LRRK2\n### PARKINSON’S DISEASE AND ALPHA-SYNUCLEIN AGGREGATION\n### EXISTING LRRK2 BIOMARKERS\n### LRRK2 AND LYSOSOMAL DYSFUNCTION","[{\"question\":\"What is the primary objective of the LITE study?\",\"answer\":\"To identify critical biological markers for LRRK2-driven Parkinson’s disease.\"},{\"question\":\"What study design and study duration are specified?\",\"answer\":\"The study uses a cross-sectional, observational design, with a planned study period of 2 years and clinical phase duration up to 30 days.\"},{\"question\":\"Who serves as the U.S. principal investigator and what is their role?\",\"answer\":\"Thomas Tropea, DO serves as the U.S. Principal Investigator (PI). The PI is responsible for conducting the study within the U.S., with site investigators overseeing conduct at their respective sites under PI oversight.\"}]","THE MJFF LITE STUDY PROTOCOL - U.S. Protocol Approval - 027 | PDF",78]