{"title":"Lecanemab 之外:考察阿尔茨海默氏症疗法的 III 期潜力","authors":"Hitoshi Osaka, Keiichiro Nishida, Tetsufumi Kanazawa","doi":"10.1002/pcn5.185","DOIUrl":null,"url":null,"abstract":"This review focuses on the development of therapeutic interventions for Alzheimer's dementia. While established treatments targeted acetylcholine and NMDA receptors, there is a growing demand for innovative therapies as the aging population increases. The paper highlights the US Food and Drug Administration's approval of aducanumab (Aduhelm) and lecanemab (Leqembi), emphasizing the developmental status of new treatments. Specifically, it covers seven principal drugs in Phase III trials, detailing their mechanisms of action, clinical trial specifics in the United States and Japan, and the current status of regulatory applications. The review focuses on amyloid removal (donanemab), tau protein mitigation (E2814), drug repositioning (Semaglutide, GV1001), and disease‐modifying small molecules (fosgonimeton, hydralazine, masitinib). However, Gantenerumab and Solanezumab, unsuccessful in Phase III, are not covered. While the future approval status remains uncertain, we hope these drugs will offer beneficial therapeutic effects for potential dementia patients.","PeriodicalId":507124,"journal":{"name":"Psychiatry and Clinical Neurosciences Reports","volume":"162 8","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Beyond lecanemab: Examining Phase III potential in Alzheimer's therapeutics\",\"authors\":\"Hitoshi Osaka, Keiichiro Nishida, Tetsufumi Kanazawa\",\"doi\":\"10.1002/pcn5.185\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This review focuses on the development of therapeutic interventions for Alzheimer's dementia. While established treatments targeted acetylcholine and NMDA receptors, there is a growing demand for innovative therapies as the aging population increases. The paper highlights the US Food and Drug Administration's approval of aducanumab (Aduhelm) and lecanemab (Leqembi), emphasizing the developmental status of new treatments. Specifically, it covers seven principal drugs in Phase III trials, detailing their mechanisms of action, clinical trial specifics in the United States and Japan, and the current status of regulatory applications. The review focuses on amyloid removal (donanemab), tau protein mitigation (E2814), drug repositioning (Semaglutide, GV1001), and disease‐modifying small molecules (fosgonimeton, hydralazine, masitinib). However, Gantenerumab and Solanezumab, unsuccessful in Phase III, are not covered. While the future approval status remains uncertain, we hope these drugs will offer beneficial therapeutic effects for potential dementia patients.\",\"PeriodicalId\":507124,\"journal\":{\"name\":\"Psychiatry and Clinical Neurosciences Reports\",\"volume\":\"162 8\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Psychiatry and Clinical Neurosciences Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/pcn5.185\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychiatry and Clinical Neurosciences Reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/pcn5.185","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
本综述侧重于阿尔茨海默氏症痴呆症治疗干预措施的开发。虽然已有的治疗方法针对乙酰胆碱和 NMDA 受体,但随着老龄化人口的增加,对创新疗法的需求也在不断增长。本文重点介绍了美国食品和药物管理局批准阿杜单抗(aducanumab,Aduhelm)和利坎单抗(lecanemab,Leqembi)的情况,强调了新疗法的发展状况。具体而言,它涵盖了七种处于 III 期试验阶段的主要药物,详细介绍了它们的作用机制、美国和日本的临床试验具体情况以及监管申请的现状。综述的重点是淀粉样蛋白清除(多那尼单抗)、tau 蛋白缓解(E2814)、药物重新定位(塞马鲁肽、GV1001)和疾病改变小分子药物(福斯戈尼米通、水蛭素、马西替尼)。然而,Gantenerumab 和 Solanezumab 在 III 期未取得成功,因此未被涵盖在内。虽然未来的批准情况仍不确定,但我们希望这些药物能为潜在的痴呆症患者提供有益的治疗效果。
Beyond lecanemab: Examining Phase III potential in Alzheimer's therapeutics
This review focuses on the development of therapeutic interventions for Alzheimer's dementia. While established treatments targeted acetylcholine and NMDA receptors, there is a growing demand for innovative therapies as the aging population increases. The paper highlights the US Food and Drug Administration's approval of aducanumab (Aduhelm) and lecanemab (Leqembi), emphasizing the developmental status of new treatments. Specifically, it covers seven principal drugs in Phase III trials, detailing their mechanisms of action, clinical trial specifics in the United States and Japan, and the current status of regulatory applications. The review focuses on amyloid removal (donanemab), tau protein mitigation (E2814), drug repositioning (Semaglutide, GV1001), and disease‐modifying small molecules (fosgonimeton, hydralazine, masitinib). However, Gantenerumab and Solanezumab, unsuccessful in Phase III, are not covered. While the future approval status remains uncertain, we hope these drugs will offer beneficial therapeutic effects for potential dementia patients.