Faculty Profiles - HASHIZUME Atsushi

Papers - HASHIZUME Atsushi

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Post–marketing clinical study of leuprorelin acetate for spinal and bulbar muscular atrophy Reviewed Open Access

Hashizume Atsushi

Neurological Therapeutics Vol. 42 ( 4 ) page： 632 - 636 2025

Language：Japanese Publishing type：Research paper (scientific journal) Publisher：Japanese Society of Neurological Therapeutics

In Japan, many new drugs for neurodegenerative diseases have been developed in recent years, with translational research playing a key role, exemplified by leuprorelin acetate for SBMA. Clinical trials often fail to confirm the long–term efficacy of disease–modifying therapies for slowly progressive neuromuscular diseases, highlighting the need for post–marketing clinical studies. Real–world data, exceptionally patient registries, has become increasingly important when clinical trial data alone is insufficient. Our study evaluated the real–world efficacy of leuprorelin acetate for SBMA using trend–shift analysis, demonstrating a practical method for assessing drug effectiveness in post–marketing research.

DOI： 10.15082/jsnt.42.4_632

Open Access

CiNii Research

国内外の患者会との連携 Reviewed Open Access

山田晋一郎, 橋詰淳, 勝野雅央

神経治療学 Vol. 42 ( 6 ) page： S191 - S191 2025

Comparison of Early-onset Efficacy of Anti-calcitonin Gene-related Peptide Monoclonal Antibodies for Patients with Migraine in Real-world Clinical Practice: Study Protocol for an Exploratory Clinical Trial. Open Access

Takafumi Tanei, Satoshi Maesawa, Yusuke Nishimura, Tomotaka Ishizaki, Yoshitaka Nagashima, Miki Hashida, Shun Yamamoto, Masahiko Ando, Yachiyo Kuwatsuka, Atsushi Hashizume, Toshihiko Wakabayashi, Ryuta Saito

Neurologia medico-chirurgica Vol. 65 ( 2 ) page： 71 - 80 2024.12

Language：English Publishing type：Research paper (scientific journal) Publisher：The Japan Neurosurgical Society

Three anti-calcitonin gene-related peptide monoclonal antibodies (CGRP-mAbs) are available in Japan: galcanezumab, fremanezumab, and erenumab. Early-onset efficacy has been demonstrated for each CGRP-mAb in comparison with placebo, but differences among the drugs are unclear. Only galcanezumab requires 2 doses at the initial injection. This study is a multicenter, open-label, randomized, two-group comparison trial, consisting of the random selection of a CGRP-mAb and 6 consecutive injections, and then discontinuation of the CGRP-mAb after 6 injections. The primary outcome is a comparison of early-onset efficacy between galcanezumab and both fremanezumab and erenumab after the initial injection. The secondary outcomes are comparisons between galcanezumab and both fremanezumab and erenumab, and between fremanezumab and erenumab as follows: weekly number of headache days, migraine days, and acute medication use are compared to baseline during one month after initial injection; time of subjectively perceiving onset of effect after initial injection; monthly changes in headache status from baseline to after third (3rd) injections; effective rates after initial and 3rd injections; improvement rates of depression scores between baseline and after 3rd injections; changes in number of absenteeism and presenteeism days in each month from baseline to after 3rd injections; proportion of ineffective cases after 3rd injections; recurrence rates and time to recurrence after CGRP-mAb discontinuation; effective rates of CGRP-mAb re-injections; detection of clinical factors associated with effectiveness after the initial and 3rd injections. The aim of this study is to investigate differences in early-onset efficacy among the CGRP-mAbs, and when and to what extent headache symptoms recur after discontinuation.

DOI： 10.2176/jns-nmc.2024-0201

Conventional magnetic resonance imaging key features for distinguishing pathologically confirmed corticobasal degeneration from its mimics: a retrospective analysis of the J-VAC study. Reviewed International journal

Keita Sakurai, Aya M Tokumaru, Mari Yoshida, Yuko Saito, Koichi Wakabayashi, Takashi Komori, Masato Hasegawa, Takeshi Ikeuchi, Yuichi Hayashi, Takayoshi Shimohata, Shigeo Murayama, Yasushi Iwasaki, Toshiki Uchihara, Motoko Sakai, Ichiro Yabe, Satoshi Tanikawa, Hiroshi Takigawa, Tadashi Adachi, Ritsuko Hanajima, Harutoshi Fujimura, Kentaro Hayashi, Keizo Sugaya, Kazuko Hasegawa, Terunori Sano, Masaki Takao, Osamu Yokota, Tomoko Miki, Michio Kobayashi, Nobutaka Arai, Takuya Ohkubo, Takanori Yokota, Keiko Mori, Masumi Ito, Chiho Ishida, Jiro Idezuka, Yasuko Toyoshima, Masato Kanazawa, Masashi Aoki, Takafumi Hasegawa, Hirohisa Watanabe, Atsushi Hashizume, Hisayoshi Niwa, Keizo Yasui, Keita Ito, Yukihiko Washimi, Akatsuki Kubota, Tatsushi Toda, Kenji Nakashima, Ikuko Aiba

Neuroradiology Vol. 66 ( 11 ) page： 1917 - 1929 2024.11

Language：English Publishing type：Research paper (scientific journal)

PURPOSE: Due to the indistinguishable clinical features of corticobasal syndrome (CBS), the antemortem differentiation between corticobasal degeneration (CBD) and its mimics remains challenging. However, the utility of conventional magnetic resonance imaging (MRI) for the diagnosis of CBD has not been sufficiently evaluated. This study aimed to investigate the diagnostic performance of conventional MRI findings in differentiating pathologically confirmed CBD from its mimics. METHODS: Semiquantitative visual rating scales were employed to assess the degree and distribution of atrophy and asymmetry on conventional T1-weighted and T2-weighted images. Additionally, subcortical white matter hyperintensity (SWMH) on fluid-attenuated inversion recovery images were visually evaluated. RESULTS: In addition to 19 patients with CBD, 16 with CBD mimics (progressive supranuclear palsy (PSP): 9, Alzheimer's disease (AD): 4, dementia with Lewy bodies (DLB): 1, frontotemporal lobar degeneration with TAR DNA-binding protein of 43 kDa(FTLD-TDP): 1, and globular glial tauopathy (GGT): 1) were investigated. Compared with the CBD group, the PSP-CBS subgroup showed severe midbrain atrophy without SWMH. The non-PSP-CBS subgroup, comprising patients with AD, DLB, FTLD-TDP, and GGT, showed severe temporal atrophy with widespread asymmetry, especially in the temporal lobes. In addition to over half of the patients with CBD, two with FTLD-TDP and GGT showed SWMH, respectively. CONCLUSION: This study elucidates the distinct structural changes between the CBD and its mimics based on visual rating scales. The evaluation of atrophic distribution and SWMH may serve as imaging biomarkers of conventional MRI for detecting background pathologies.

DOI： 10.1007/s00234-024-03432-w

Web of Science

Scopus

PubMed

Phase II/III and efficacy confirmation study of aceneuramic acid for GNE myopathy in Japan Reviewed

Suzuki, N; Yoshimura, MM; Katsuno, M; Takahashi, M; Yamashita, S; Oya, Y; Hashizume, A; Yamada, S; Nakamori, M; Izumi, R; Kato, M; Warita, H; Tateyama, M; Kuroda, H; Asada, R; Yamaguchi, T; Nishino, I; Aoki, M

NEUROMUSCULAR DISORDERS Vol. 43 2024.10

脊髄小脳変性症患者に対するHAL腰タイプを用いた在宅運動療法 Reviewed

岸本祥之, 橋詰淳, 山田晋一郎, 伊藤大輔, 小森祥太, 川瀬崇広, 近藤彩乃, 小原一輝, 森悠, 山本宗隆, 阿部友和, 戸田莉恵, 安永好宏, 勝野雅央

神経治療学 Vol. 41 ( 6 ) page： S299 - S299 2024.10

球脊髄性筋萎縮症における骨脆弱性への治療法の検討 Reviewed

川瀬崇広, 橋詰淳, 山田晋一郎, 伊藤大輔, 岸本祥之, 小森祥太, 近藤彩乃, 森悠, 小原一輝, 山本宗隆

神経治療学 Vol. 41 ( 6 ) page： S280 - S280 2024.10

リアルワールドデータを用いた球脊髄性筋萎縮症に対するリュープロレリン酢酸塩の有効性評価 Reviewed

橋詰淳, 花澤遼一, 山田晋一郎, 伊藤大輔, 岸本祥之, 小森祥太, 川瀬崇広, 近藤彩乃, 佐藤宏征, 平川晃弘, 山本知孝, 森田光哉, 勝野雅央

神経治療学 Vol. 41 ( 6 ) page： S292 - S292 2024.10

脊髄小脳変性症患者に対するHAL腰タイプを用いた在宅運動療法 Reviewed

岸本祥之, 橋詰淳, 山田晋一郎, 伊藤大輔, 小森祥太, 川瀬崇広, 近藤彩乃, 小原一輝, 森悠, 山本宗隆, 阿部友和, 戸田莉恵, 安永好宏, 勝野雅央

神経治療学 Vol. 41 ( 6 ) page： S299 - S299 2024.10

脂肪酸アミド加水分解酵素(FAAH)阻害薬による筋萎縮性側索硬化症の治療 Reviewed

伊藤大輔, 飯田円, 井口洋平, 橋詰淳, 山田晋一郎, 岸本祥之, 小森祥太, 島村徹平, 竹本悠人, 中杤昌弘, 紅朋浩, 日野原邦彦, 李賢哲, 丹羽淳一, 祖父江元, 田中慎治, 高科謙, 横溝岳彦, 勝野雅央

神経治療学 Vol. 41 ( 6 ) page： S279 - S279 2024.10

球脊髄性筋萎縮症患者における遺伝リテラシーの国際的調査 Reviewed

山田晋一郎, 橋詰淳, 伊藤大輔, 岸本祥之, 小森祥太, 川瀬崇広, 近藤彩乃, 勝野雅央

臨床神経学 Vol. 64 ( Suppl. ) page： S348 - S348 2024.10

球脊髄性筋萎縮症における骨脆弱性への治療法の検討 Reviewed

川瀬崇広, 橋詰淳, 山田晋一郎, 伊藤大輔, 岸本祥之, 小森祥太, 近藤彩乃, 森悠, 小原一輝, 山本宗隆

神経治療学 Vol. 41 ( 6 ) page： S280 - S280 2024.10

球脊髄性筋萎縮症における骨脆弱性の検討 Reviewed

川瀬崇広, 橋詰淳, 山田晋一郎, 伊藤大輔, 岸本祥之, 小森祥太, 近藤彩乃, 勝野雅央

臨床神経学 Vol. 64 ( Suppl. ) page： S240 - S240 2024.10

孤発性筋萎縮性側索硬化症における発症前症状の検討 Reviewed

小森祥太, 伊藤大輔, 橋詰淳, 山田晋一郎, 岸本祥之, 川瀬崇広, 近藤彩乃, 勝野雅央

臨床神経学 Vol. 64 ( Suppl. ) page： S284 - S284 2024.10

医療データに基づいた球脊髄性筋萎縮症に対するリュープロレリン酢酸塩の有効性評価 Reviewed

橋詰淳, 山田晋一郎, 伊藤大輔, 岸本祥之, 小森祥太, 川瀬崇広, 近藤綾乃, 花澤遼一, 佐藤宏征, 平川晃弘, 森田光哉, 山本知孝, 勝野雅央

臨床神経学 Vol. 64 ( Suppl. ) page： S240 - S240 2024.10

AUTOANTIBODIES AGAINST DIHYDROLIPOAMIDE S-ACETYLTRANSFERASE IN IMMUNE-MEDIATED NEUROPATHIES Reviewed

Fukami, Y; Iijima, M; Koike, H; Yagi, S; Furukawa, S; Mouri, N; Ouchida, J; Murakami, A; Iida, M; Yokoi, S; Hashizume, A; Iguchi, Y; Imagama, S; Katsuno, M

JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM Vol. 29 page： S184 - S184 2024.8

Comparing preprocessing strategies for 3D-Gene microarray data of extracellular vesicle-derived miRNAs. Reviewed International journal Open Access

Yuto Takemoto, Daisuke Ito, Shota Komori, Yoshiyuki Kishimoto, Shinichiro Yamada, Atsushi Hashizume, Masahisa Katsuno, Masahiro Nakatochi

BMC bioinformatics Vol. 25 ( 1 ) page： 221 - 221 2024.6

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Extracellular vesicle-derived (EV)-miRNAs have potential to serve as biomarkers for the diagnosis of various diseases. miRNA microarrays are widely used to quantify circulating EV-miRNA levels, and the preprocessing of miRNA microarray data is critical for analytical accuracy and reliability. Thus, although microarray data have been used in various studies, the effects of preprocessing have not been studied for Toray's 3D-Gene chip, a widely used measurement method. We aimed to evaluate batch effect, missing value imputation accuracy, and the influence of preprocessing on measured values in 18 different preprocessing pipelines for EV-miRNA microarray data from two cohorts with amyotrophic lateral sclerosis using 3D-Gene technology. RESULTS: Eighteen different pipelines with different types and orders of missing value completion and normalization were used to preprocess the 3D-Gene microarray EV-miRNA data. Notable results were suppressed in the batch effects in all pipelines using the batch effect correction method ComBat. Furthermore, pipelines utilizing missForest for missing value imputation showed high agreement with measured values. In contrast, imputation using constant values for missing data exhibited low agreement. CONCLUSIONS: This study highlights the importance of selecting the appropriate preprocessing strategy for EV-miRNA microarray data when using 3D-Gene technology. These findings emphasize the importance of validating preprocessing approaches, particularly in the context of batch effect correction and missing value imputation, for reliably analyzing data in biomarker discovery and disease research.

DOI： 10.1186/s12859-024-05840-4

Safety and efficacy of aceneuramic acid in GNE myopathy: open-label extension study. Reviewed International journal

Naoki Suzuki, Madoka Mori-Yoshimura, Masahisa Katsuno, Masanori P Takahashi, Satoshi Yamashita, Yasushi Oya, Atsushi Hashizume, Shinichiro Yamada, Masayuki Nakamori, Rumiko Izumi, Masaaki Kato, Hitoshi Warita, Maki Tateyama, Hiroshi Kuroda, Ryuta Asada, Takuhiro Yamaguchi, Ichizo Nishino, Masashi Aoki

Journal of neurology, neurosurgery, and psychiatry Vol. 95 ( 11 ) page： 1093 - 1094 2024.6

Autoantibodies Against Dihydrolipoamide S-Acetyltransferase in Immune-Mediated Neuropathies. Reviewed International journal

Yuki Fukami, Masahiro Iijima, Haruki H Koike, Satoru Yagi, Soma Furukawa, Naohiro Mouri, Jun Ouchida, Ayuka Murakami, Madoka Iida, Satoshi Yokoi, Atsushi Hashizume, Yohei Iguchi, Shiro Imagama, Masahisa Katsuno

Neurology(R) neuroimmunology & neuroinflammation Vol. 11 ( 2 ) page： e200199 2024.3

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND AND OBJECTIVES: This study aimed to identify disease-related autoantibodies in the serum of patients with immune-mediated neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP) and to investigate the clinical characteristics of patients with these antibodies. METHODS: Proteins extracted from mouse brain tissue were used to react with sera from patients with CIDP by western blotting (WB) to determine the presence of common bands. Positive bands were then identified by mass spectrometry and confirmed for reactivity with patient sera using enzyme-linked immunosorbent assay (ELISA) and WB. Reactivity was further confirmed by cell-based and tissue-based indirect immunofluorescence assays. The clinical characteristics of patients with candidate autoantibody-positive CIDP were analyzed, and their association with other neurologic diseases was also investigated. RESULTS: Screening of 78 CIDP patient sera by WB revealed a positive band around 60-70 kDa identified as dihydrolipoamide S-acetyltransferase (DLAT) by immunoprecipitation and mass spectrometry. Serum immunoglobulin G (IgG) and IgM antibodies' reactivity to recombinant DLAT was confirmed using ELISA and WB. A relatively high reactivity was observed in 29 of 160 (18%) patients with CIDP, followed by patients with sensory neuropathy (6/58, 10%) and patients with MS (2/47, 4%), but not in patients with Guillain-Barré syndrome (0/27), patients with hereditary neuropathy (0/40), and healthy controls (0/26). Both the cell-based and tissue-based assays confirmed reactivity in 26 of 33 patients with CIDP. Comparing the clinical characteristics of patients with CIDP with anti-DLAT antibodies (n = 29) with those of negative cases (n = 131), a higher percentage of patients had comorbid sensory ataxia (69% vs 37%), cranial nerve disorders (24% vs 9%), and malignancy (20% vs 5%). A high DLAT expression was observed in human autopsy dorsal root ganglia, confirming the reactivity of patient serum with mouse dorsal root ganglion cells. DISCUSSION: Reactivity to DLAT was confirmed in patient sera, mainly in patients with CIDP. DLAT is highly expressed in the dorsal root ganglion cells, and anti-DLAT antibody may serve as a biomarker for sensory-dominant neuropathies.

DOI： 10.1212/NXI.0000000000200199

Web of Science

Scopus

PubMed

PMDA experience and current work ―Clinical research support in academia― Reviewed

Hashizume Atsushi

Neurological Therapeutics Vol. 41 ( 3 ) page： 411 - 414 2024

Language：Japanese Publishing type：Research paper (scientific journal) Publisher：Japanese Society of Neurological Therapeutics

As a pioneer of investigator–initiated clinical trials in Japan, Nagoya University started a multi–institutional Phase III study (JASMITT trial) to evaluate the efficacy and safety of leuprorelin acetate in the patients with Spinal and Bulbar Muscular Atrophy (SBMA) in 2006. The JASMITT trial is a translational study based on basic research findings on animal models of SBMA. In investigator–initiated new drug developments, academic researchers often need help to prepare a complete clinical data package. Experience with PMDA may lead to better preparation of regulatory filings. The author joined the New Drug Review 2 of the Pharmaceutical and Medical Device Agency (PMDA) in April 2013, during the clinical development of leuprorelin acetate, and learned the actual operations of consultation and new drug reviews. After that, leuprorelin acetate got approval based on the investigator–initiated clinical trials in 2017.In April 2021, the Department of Clinical Research Education (CRE) opened at the Nagoya University Graduate School of Medicine to promote clinical researches at Nagoya University. The two essential missions of CRE are “clinical research education” and “clinical research support”. CRE could be the only department to comprehensively deepen understanding and practice from observational researches to clinical trials.

DOI： 10.15082/jsnt.41.3_411

CiNii Research

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Papers - HASHIZUME Atsushi