セッション詳細
[S-36]シンポジウム36 Global Perspective on ALS issues and Strategies
2025年5月23日(金) 15:00 〜 17:00
第04会場(大阪国際会議場10F 会議室1001-1002)
座長：青木 正志（東北大学大学院医学系研究科 神経内科学）, 漆谷 真（国立大学法人 滋賀医科大学 内科学講座 脳神経内科）
ALS has recently been the most common neuromuscular disease in terms of the number of clinical trials. However, most of the past ALS clinical trials have failed except for riluzole and edaravone.In this symposium, we will be discussing the Japanese registry system (JaCALS), the establishment of genetic testing for nucleic acid medicine (J-FAST), the development of guidelines for ALS clinical trials, the harmonization of clinical evaluations such as ALSFRS-R, the implementation of efficient adaptive trials for ALS, and patient and public involvement (PPI). We will learn from the failures of past ALS clinical trials and develop strategies for future ALS drug development.
[S-36-1]我が国のALS患者レジストリ（JaCALS）を基盤としたALS治療開発戦略
熱田 直樹1, 中村 亮一1, 藤内 玄規2, 祖父江 元3 (1.愛知医科大学医学部 内科学講座（神経内科）, 2.愛知医科大学ALS治療研究開発部門, 3.愛知医科大学)
Naoki Atsuta graduated from Nagoya University School of Medicine in 1996. After completing his clinical training, he became a neurologist and earned his degree from Nagoya University Graduate School of Medicine. He served as the ward chief of Neurology at Nagoya University Hospital from 2009 to 2020. Since November 2020, he has been working as an Associate Professor at Aichi Medical University.
Since 2005, he has been a central contributor to the establishment, operation, and analysis of JaCALS, a registry of ALS patients in Japan. He has also participated as a site principal investigator (PI) in many ALS clinical trials, including those for edaravone and methylcobalamin. Additionally, he is a member of the ALS Clinical Guidelines Committee of the Japanese Society of Neurology and is also a member of the committee working on the clinical evaluation guidelines for ALS clinical trials.
Since 2005, he has been a central contributor to the establishment, operation, and analysis of JaCALS, a registry of ALS patients in Japan. He has also participated as a site principal investigator (PI) in many ALS clinical trials, including those for edaravone and methylcobalamin. Additionally, he is a member of the ALS Clinical Guidelines Committee of the Japanese Society of Neurology and is also a member of the committee working on the clinical evaluation guidelines for ALS clinical trials.
[S-36-2]Prospects of the Japan Familial ALS Trial-ready Registry (J-FAST)
鈴木 直輝1, 西山 亜由美2, 青木 正志2 (1.東北大学大学院医学系研究科 臨床障害学, 2.東北大学大学院医学系研究科 神経内科学)
Curriculum Vitae
2001 Graduated from Tohoku University School of Medicine
2001-2002 Department of Neurology, Tohoku University Hospital
2002-2003 Iwaki Kyoritsu Hospital & Tohoku Kosei Nenkin Hospital
2003-2007 Department of Neurology, Tohoku University School of Medicine
2004-2007 Graduate study at Department of Molecular Therapy, National Institute of Neuroscience
2007-2011 Clinical Fellow at Department of Neurology, Tohoku University Hospital
2011 Assistant Professor at Department of Neurology, Tohoku University Hospital
2011-2014 Postdoctoral Fellow, Eggan Lab, SCRB, HSCI, Harvard University
2014-2019 Assistant Professor at Department of Neurology, Tohoku University Hospital
2019-2020 Chief physician, Department of Neurology, Shodo-kai Southern Tohoku General Hospital
2019-2023 Assistant Professor at Department of Neurology, Tohoku University Hospital
2024-Senior Lecturer at Department of Rehabilitation Medicine, Tohoku University Graduate School of Medicine
2001 Graduated from Tohoku University School of Medicine
2001-2002 Department of Neurology, Tohoku University Hospital
2002-2003 Iwaki Kyoritsu Hospital & Tohoku Kosei Nenkin Hospital
2003-2007 Department of Neurology, Tohoku University School of Medicine
2004-2007 Graduate study at Department of Molecular Therapy, National Institute of Neuroscience
2007-2011 Clinical Fellow at Department of Neurology, Tohoku University Hospital
2011 Assistant Professor at Department of Neurology, Tohoku University Hospital
2011-2014 Postdoctoral Fellow, Eggan Lab, SCRB, HSCI, Harvard University
2014-2019 Assistant Professor at Department of Neurology, Tohoku University Hospital
2019-2020 Chief physician, Department of Neurology, Shodo-kai Southern Tohoku General Hospital
2019-2023 Assistant Professor at Department of Neurology, Tohoku University Hospital
2024-Senior Lecturer at Department of Rehabilitation Medicine, Tohoku University Graduate School of Medicine
[S-36-3]Guidelines for ALS Drug Evaluation in Japan: Challenges and Global Collaboration
藤田 浩司 (徳島大学大学院医歯薬学研究部臨床神経科学分野)
May 2002: Resident, Department of Neurology, Tokushima University Hospital
June 2003: Resident, Kohnodai Hospital, National Center of Neurology and Psychiatry
October 2005: Fellow, Department of Neurology, Tokushima University Hospital
April 2012: Designated Assistant Professor, Department of Neurology, Tokushima University Hospital
August 2012: Assistant Professor, Department of Clinical Neuroscience, Institute of Health Biosciences, Tokushima University Graduate School
August 2014: Postdoctoral Fellow, Center for Neurosciences, The Feinstein Institute for Medical Research
April 2018: Designated Assistant Professor, Department of Neurology, Tokushima University Hospital
April 2020: Designated Associate Professor, Department of Neurology, Tokushima University Hospital
May 2021: Associate Professor, Department of Neurology, Tokushima University Graduate School of Biomedical Sciences (current position)
June 2003: Resident, Kohnodai Hospital, National Center of Neurology and Psychiatry
October 2005: Fellow, Department of Neurology, Tokushima University Hospital
April 2012: Designated Assistant Professor, Department of Neurology, Tokushima University Hospital
August 2012: Assistant Professor, Department of Clinical Neuroscience, Institute of Health Biosciences, Tokushima University Graduate School
August 2014: Postdoctoral Fellow, Center for Neurosciences, The Feinstein Institute for Medical Research
April 2018: Designated Assistant Professor, Department of Neurology, Tokushima University Hospital
April 2020: Designated Associate Professor, Department of Neurology, Tokushima University Hospital
May 2021: Associate Professor, Department of Neurology, Tokushima University Graduate School of Biomedical Sciences (current position)
[S-36-4]Harmonized ALSFRS-R
Angela Genge (McGill University)
Dr. Angela Genge is Director of the ALS Clinic and Executive Director of the ALS Center of Excellence at The Neuro, Montreal Neurological Institute-Hospital. She earned her MD at Memorial University of Newfoundland, completed residencies at McGill University, and a Fellowship in Neuromuscular Diseases at The Neuro, achieving Canadian and American certifications in internal medicine and neurology.
From 2004 to 2023, Dr. Genge led The Neuro’s Clinical Research Unit, transforming it into one of Canada’s largest neurological research centers, including a pioneering Phase 1 Unit for neurological diseases. She is an internationally recognized leader in clinical research, specializing in rare neurological disorders. She has conducted trials in ALS, dementias, neuropathies, myopathies, myasthenia gravis, and pain, with extensive expertise in trial design, drug development, regulatory affairs, and real-world evidence programs.
She consults for biotech companies specializing in rare diseases. Dr. Genge has served on numerous advisory and safety boards. Her contributions have earned prestigious honors, including the 2023 Wings Over Wall Street Award, 2018 Forbes Norris Award, and Governor General’s Diamond Jubilee Award.
Currently, Dr. Genge leads ACCESS ALS and serves on executive committees for CAPTURE ALS, TRICALS, Precision ALS, the ALS Network, and the WFN MND Study Group.
From 2004 to 2023, Dr. Genge led The Neuro’s Clinical Research Unit, transforming it into one of Canada’s largest neurological research centers, including a pioneering Phase 1 Unit for neurological diseases. She is an internationally recognized leader in clinical research, specializing in rare neurological disorders. She has conducted trials in ALS, dementias, neuropathies, myopathies, myasthenia gravis, and pain, with extensive expertise in trial design, drug development, regulatory affairs, and real-world evidence programs.
She consults for biotech companies specializing in rare diseases. Dr. Genge has served on numerous advisory and safety boards. Her contributions have earned prestigious honors, including the 2023 Wings Over Wall Street Award, 2018 Forbes Norris Award, and Governor General’s Diamond Jubilee Award.
Currently, Dr. Genge leads ACCESS ALS and serves on executive committees for CAPTURE ALS, TRICALS, Precision ALS, the ALS Network, and the WFN MND Study Group.
[S-36-5]ALS研究と臨床試験の活性化に向けて
狩野 修, 渋川 茉莉, 平山 剛久 (東邦大学医学部内科学講座 神経内科学分野)
Dr. Osamu Kano is currently a Professor and Chairperson of the Department of Neurology, Toho University Faculty of Medicine. He completed his medical degree and PhD in Neurology at Toho University. He continued to develop his skills as a neurologist at the Tokyo Metropolitan Institute for Neuroscience, the National Center of Neurology and Psychiatry, and NTT East Corporation Kanto Medical Center. He has been a postdoctoral researcher since 2007 under Professor Stanley Appel at Houston Methodist Hospital, where he studied the pathology of ALS using model mice. After returning to Japan in 2011, he focused on identifying biomarkers from peripheral blood in ALS patients to promote future clinical trials. His ALS clinic became the first in Asia to be certified as a NEALS site in 2020. He aims to work with overseas consortiums to conduct efficient clinical trials globally.