How Multiple Sclerosis Symptoms Vary by Age, Sex, and Race/Ethnicity

Biogen Idec MS Franchise Data Generation Advisory Board Genentech Advisory Board EMDSerono Advisory Board Alexion Advisory Board

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'Top 100 Diagnoses in Neurology' published by Wolters Kluwer in 2020.

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Biogen Idec one-time consulting fee Roche consulting fee

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Received research support from Biogen-Idec, Serono, Novartis, Genzyme, Genentech

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(1) Guthy-Jackson Charitable Foundation (2) National Multiple Sclerosis Society

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Biogen Idec MS Franchise Data Generation Advisory Board Genentech Advisory Board EMDSerono Advisory Board Alexion Advisory Board

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'Top 100 Diagnoses in Neurology' published by Wolters Kluwer in 2020.

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Biogen Idec one-time consulting fee Roche consulting fee

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Received research support from Biogen-Idec, Serono, Novartis, Genzyme, Genentech

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(1) Guthy-Jackson Charitable Foundation (2) National Multiple Sclerosis Society

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Data and Safety Monitoring Boards: Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Horizon Pharmaceuticals,Hisun Pharmaceuticals, Mapi Pharmaceuticals LTD, Merck, Merck/Pfizer, Opko Biologics, OncoImmune, Neurim, Novartis, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Teva pharmaceuticals, VielaBio Inc, Vivus, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee).

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Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Neurogenesis, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion Pharmaceuticals, Roche, Somahlution, TG Therapeutics.

Am journal of the Society of Nephrology. Statistical Reviewer; contributinng statistical help (4 yrs); Alzheimer's and Dementia (3) yrs; Neurology Clinical Practice (5yrs)

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Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Roche, TG Therapeutics.

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President of Pythagoras Inc. a consulting company...gc

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NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U19-AI113212 Name of Principal Investigator: Gary Cutter Funding Source: NIH/NIAID Title of Project (or Subproject):The UAB STI CRC- DiSCIS Biostatistics & Bioinformatics Core Dates of Approved/Proposed Project: 6/15/2014 – 5/31/2019 Annual Direct Costs: $1,418,940 Percent Effort: 1% What are the specific aims of this project? This study establishes a Sexually Transmitted Infections Cooperative Research Center comprised of a group of innovative, multidisciplinary translational research projects with the goal of addressing the microbial origins and pathogenesis of the most prevalent genital discharge syndromes in men (non-gonococcal urethritis) and women (bacterial vaginosis), as well as the interaction of these syndromes with the most prevalent sexually transmitted bacteria, Chlamydia trachomatis. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01-HL119242 Name of Principal Investigator: Gary Cutter Funding Source: NIH/NHLBI Title of Project (or Subproject): Chronic Hyperten- sion and Pregnancy (CHAP): Data Coordinating Center Dates of Approved/Proposed Project: 9/1/2014 – 11/30/2020 Annual Direct Costs: $399,734 Percent Effort: 7.5% What are the specific aims of this project? This is a large pragmatic multi-center randomized trial of pregnant women with mild chronic hypertension to evaluate the benefits and harms of antihypertensive therapy to a goal <140/90 mmHg (as recommended for the general population in the US) compared with ACOG's current policy of expectant management of mild chronic hypertension in pregnancy. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Project Number: W81XWH-12-1-0155 Name of Principal Investigator: Bruce Korf Funding Source: U.S. Department of Defense Title of Project (or Subproject): Neurofibromatosis Clinical Consortium Award Dates of Approved/Proposed Project: 5/15/2012 – 5/14/2019 Annual Direct Costs: $333,333 Percent Effort: 3% What are the specific aims of this project? This is a cooperative study group that is focusing on multiple trials in NF. The role of the operations center is both as the data center and the overall coordinating of the study group. (NF) NAME OF PROFESSIONAL: Agarwal Is this project active or pending? Active Project Number: P30 DK079337 Name of Principal Investigator: Anupam Agarwal Funding Source: NIH/NIDDK Title of Project (or Subproject): UAB/UCSD O’Brien Core Center for Acute Kidney Injury Research Dates of Approved/Proposed Project: 9/20/2013 – 7/31/2019 Annual Direct Costs: $923,595 Percent Effort: 5% What are the specific aims of this project? In summary, these cores and the outstanding cohort of investigators assembled for this center will provide unique expertise that is critical for innovative and productive research in AKI. With its Extended Research Base, that includes both clinical and basic investigators, this O'Brien center will accelerate the translation of new investigative insights towards novel therapies for patients with AKI. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: P2C HD086851 Name of Principal Investigator: Bamman, MM Funding Source: NIH/NICHHD Title of Project (or Subproject): Rehabilitation Research Resource to Enhance Clinical Trials (REACT) Dates of Approved/Proposed Project: 9/17/2015 – 6/30/2020 Annual Direct Costs:$1,052,737 Percent Effort: 15% What are the specific aims of this project? There are major knowledge gaps in medical rehabilitation that demand clinical trials of the highest quality. With particular emphasis on chronic conditions such as stroke, brain or spinal cord injury, orthopedic and joint conditions, and developmental and degenerative disorders leading to disability, the overarching purpose of the P2C Medical Rehabilitation Research Resource, based at The University of Alabama at Birmingham (UAB), is to catalyze high-impact clinical trials that will define optimal rehabilitation strategies. (P2C) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active. (turned over remove) Project Number: U01 EY025858 Name of Principal Investigator: Kristina Visscher Funding Source: NIH/National Eye Institute Title of Project (or Subproject): Changes in Visual Cortical Connectivity Following Central Visual Field Loss Dates of Approved/Proposed Project: 5/1/2016 – 4/30/2020 Annual Direct Costs: $544,961 Percent Effort: 1% What are the specific aims of this project? When people lose central vision, they must use peripheral vision to do Daily tasks like reading and recognizing faces. This proposal will examine how changes in the connectivity and structure of early visual cortex relate to this huge shift in experience. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 NS092595 Name of Principal Investigator: Martina Bebin Funding Source: NIH/NINDS Title of Project (or Subproject): Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex Dates of Approved/Proposed Project: 8/4/2016 – 8/3/2021 Annual Direct Costs:$1,792,413 Percent Effort: 5% What are the specific aims of this project? The primary objective of the study is the developmental impact of early versus delayed treatment with vigabatrin at 24 months of age based on the cognitive assessment score of the Bayley-III. (PREVENT) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: No Number Name of Principal Investigator: John Corboy Funding Source: NIH/University of Colorado Title of Project (or Subproject): Can People in Later Stages of MS Stop Taking Disease-Modifying Therapies? (The DISCO-MS Trial) Dates of Approved/Proposed Project: 5/16/2016 – 9/30/2022 Annual Direct Costs: $750,827 Percent Effort: 1% What are the specific aims of this project? This study randomizes to continue Rx or discontinuation in an older subpopulation of MS patients, to determine if DMT discontinuation is safe and results in no worse outcomes. (PCORI) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UH3 NS100553 Name of Principal Investigator: Harrison Walker Funding Source: NIH Title of Project (or Subproject): Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson’s Disease Dates of Approved/Proposed Project: 9/30/2016 – 6/30/2022 Annual Direct Costs: $1,165,696 Percent Effort: 10% What are the specific aims of this project? The goal of this research is to use minimally invasive, patient-specific cortical physiology elicited by DBS to guide the use of emerging segmented (“directional”) DBS electrode technology in patients with Parkinson’s disease. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01 HD088646 Name of Principal Investigator: Anup Katheria Funding Source: National Institute of Health Title of Project (or Subproject): Premature Infants Receiving Cord Milking Or Delayed Cord Clamping Dates of Approved/Proposed Project: 4/1/2017 – 3/31/2022 Annual Direct Costs: $557,186 Percent Effort: 2.5% What are the specific aims of this project? Delayed cord clamping reduces overall bleeding in the brain of premature infants, but not the most severe types. “Milking” the umbilical cord, a method used to transfer blood from the placenta into the baby before the umbilical cord is clamped, may provide additional blood volume to the brain and other vital organs thereby reducing bleeding in the brain and improving long-term outcomes in premature babies. This study will determine whether umbilical cord milking reduces bleeding in the brain or death in premature newborns delivered by Cesarean section compared to delaying clamping of the umbilical cord. (PREMOD2) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01 CA217179 Name of Principal Investigator: James M. Markert Funding Source: National Institute of Health Title of Project (or Subproject): A Phase 1 Study of M032, A Genetically Engineered Hsv-1 Expressing Il-12, In Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, Or Gliosarcoma Co-Investigator - Cutter Dates of Approved/Proposed Project: 5/1/2017 – 4/30/2020 Annual Direct Costs: $411,318 Percent Effort: 1.5% What are the specific aims of this project? High-grade malignant gliomas are the most prevalent intracranial malignant brain tumor in adults with a dismal prognosis evidenced by a 12-15 month median survival and a 5-year survival <5%, evincing the need for more effective therapies. We created a novel, oncolytic Herpes Simplex Virus (oHSV) termed M032 (NSC 733972) that expresses human Interleukin-12 and the NExT (NCI) program manufactured clinical grade M032 (>560 doses) for which we have been issued an investigational new drug approval (#14,946) by the FDA. We propose to conduct a first-in-human Phase I clinical trial (NCT02062827) to assess the safety and tolerability of M032, to define any unexpected toxicities, to obtain correlative biologic information, and to determine a Recommended Phase 2 Dose. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: RG-1609-25966 Name of Principal Investigator: Robert Motl Funding Source: National Multiple Sclerosis Society Title of Project (or Subproject): Project BIPAMS: Behavioral Intervention for Increasing Physical Activity in MS Dates of Approved/Proposed Project: 8/1/2017 – 7/31/2020 Annual Direct Costs: $229,200 Percent Effort: 1% What are the specific aims of this project? BIPAMS is a pilot randomized controlled trial (RCT) for a preliminary evaluation supervised, aerobic exercise training can yield improvements in physical and cognitive functioning, compared with a waitlist control condition, that are associated with an increase in aerobic fitness among older adults with MS. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 AR071133 Name of Principal Investigator: Bamman, MM Funding Source: NIH/NIAMSD Title of Project (or Subproject): The Exercise and Physical Activity Collaborative Team (ExPact): A Proposed MoTrPAC Clinical Center Dates of Approved/Proposed Project: 12/6/2016 – 11/30/2022 Annual Direct Costs: $2,114,297 Percent Effort: 3.5% What are the specific aims of this project? The goals are to help lead the NIH Common Fund initiative – Molecular Transducers of Physical Activity Consortium (MoTrPAC) – by serving as one of six adult clinical centers conducting a large-scale, randomized, controlled trial (RCT) of resistance vs. aerobic exercise training vs. no-exercise control. The RCT will be complemented by molecular acute response studies in RCT participants as well as highly trained athletes; all with the goal of generating molecular maps that reveal key underpinnings of exercise-induced health benefits. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 HL133232 Name of Principal Investigator: Duncan Funding Source: NIH/NHLBI Title of Project (or Subproject): Autoantibody-Targeted Therapy for Acute Exacerbations of Idiopathic Pulmonary Fibrosis Dates of Approved/Proposed Project: 9/1/2017 – 7/31/2022 Annual Direct Costs: $667,856 Percent Effort: 5% What are the specific aims of this project? This is a multicenter, randomized clinical trial to test specific autoantibody reduction therapies, vs. treatment as usual, in patients with acute exacerbations of idiopathic pulmonary fibrosis. Aims of this project are: 1) To conduct the trial, and compare six-month survival of the two arms; and 2) To compare effects of the treatments on secondary endpoints of a) global autoantibody levels, and b) functional assessments with 6 minute walk tests, and c) adverse events; and 3) To conduct basic immunological studies to define characteristics of the autoimmune responses in these patients that can be used to personalize therapy. (STRIVE) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UAB# 517425 Name of Principal Investigator: Brian Sandroff Funding Source: Serono Title of Project (or Subproject): Effects of Walking Exercise Training on Learning and Memory Outcomes in MS Dates of Approved/Proposed Project: 10/1/2017 – 9/30/2020 Annual Direct Costs: $367,687 Percent Effort: 1% What are the specific aims of this project? Cognitive impairment is highly prevalent, disabling, and poorly managed in persons with multiple sclerosis (MS) and exercise training might represent a promising approach for better managing this symptom of the disease. Treadmill walking has recently been identified as the exercise modality that might exert the greatest beneficial effects on cognition in MS. This investigation will provide data on potential mechanisms for how chronic exercise training might improve cognition in persons with MS NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UAB #517503 Name of Principal Investigator: Saag, K Funding Source: Horizon Pharma USA, Inc. Title of Project (or Subproject): Reducing Immunogenicity to PegloticasE (RECIPE) Dates of Approved/Proposed Project: 10/23/2017 – 10/22/2020 Current Year Direct: $618,793 Percent Effort: 12.5% What are the specific aims of this project? Double-blind, randomized, multicenter Phase II trial to evaluate preliminary efficacy of a short course of immunosuppressive therapy to prevent immunogenicity conferred by pegloticase. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: P01HL136267 Name of Principal Investigator: Pollock Funding Source: NIH/NHLBI Title of Project (or Subproject): Integrating Novel Mechanisms Controlling Sodium Excretion and Blood Pressure Dates of Approved/Proposed Project: 05/01/2017 – 03/31/2022 Annual Direct Costs: $1,756,435 Percent Effort: 5% What are the specific aims of this project? This PPG focuses on elucidating mechanisms by which the kidney controls sodium excretion, and therefore, has direct relevance to the serious health problem of salt-dependent hypertension and kidney disease. The three main projects each utilize relevant animal models and sophisticated in vitro techniques to uncover the pathways that lead to salt-dependent high blood pressure as well as uncovering ways to combat significant side effects of the relevant class of drugs known as endothelin receptor antagonists. We expect these studies will be important in guiding future clinical and therapeutic practices for a broad range of cardiovascular and related diseases NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01AG057684 Name of Principal Investigator: Kennedy Funding Source: NIH/NIA Title of Project (or Subproject): In Silico Screening of Medications for Slowing Alzheimer’s Disease Progression Dates of Approved/Proposed Project: 09/15/2017 – 03/31/2022 Annual Direct Costs: $482,787 Percent Effort: 10% What are the specific aims of this project? In this proposal, we will explore drug repurposing, in which medications approved to treat other illnesses are evaluated for potential benefits in Alzheimer's disease (AD), to improve the efficiency of the drug development process, which currently ends in failure for most candidate medications despite considerable investment of both time and resources. We will apply data mining, or pattern recognition, algorithms to the concomitant medications taken by subjects in previous AD clinical trials that are part of our meta-database of more than 6,500 individuals and by participants in Medicare Part D with more than 787,000 individuals. This approach will allow us to screen hundreds of drugs for effects in slowing the progression of AD, which will guide future clinical trials of novel therapeutic agents. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active (remove turned over) Project Number: UM1 AI68636 Name of Principal Investigator: Shacka Funding Source: NIH/Brigham& Women’s Hospital Title of Project (or Subproject): Autophagy- Lysosome Pathway Function in HIV: Effects of Antiretroviral Therapy and Relevance to Neuro- cognitive Status Dates of Approved/Proposed Project: 6/1/2017 – 5/31/2019 Annual Direct Costs: $100,000 Percent Effort: 0.08% What are the specific aims of this project? The specific aims of this project are to determine if cathepsin, cystatin B and cystatin C levels are increased in monocytes and T-cells of ART-naïve, HIV+ participants with cognitive impairment and if these putative baseline differences are attenuated by ART; and to determine if autophagic flux is inhibited in monocytes and T-cells of ART-naïve, HIV+ participants with cognitive impairment and if these putative baseline differences are attenuated by ART. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: 1R01DK108438-01 Name of Principal Investigator: Overton Funding Source: NIH/NIDD Title of Project (or Subproject): Effect of Pitavastatin on Kidney Function in HIV-infected Persons Dates of Approved/Proposed Project: 09/21/2015 – 06/30/2020 Annual Direct Costs: $466,683 Percent Effort: 1% What are the specific aims of this project? In this proposal, we will evaluate the kidney protective effect of pitavastatin and assess mechanistic pathways through which it works. We hope the results of this project will have the potential to change the management and prevention of CKD in the setting of HIV infection. (Effort in year 4)  

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The MG Registry receives funding from the Myasthenia Gravis Foundation of America

Consortium of MS Centers - Immediate past President - only expenses covered

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