{"title":"Development of disease-modifying therapies against Alzheimer's disease.","authors":"Takeshi Iwatsubo","doi":"10.1111/pcn.13681","DOIUrl":null,"url":null,"abstract":"<p><p>To successfully develop disease-modifying therapies (DMT) against Alzheimer's disease (AD), it is important to target the mild stage of the disease, before the pathological changes progress and dementia symptoms are fully manifested. To this end, the AD Neuroimaging Initiative (ADNI), a large-scale observational study, was initiated in the U.S. with the goal of development of DMT that are effective in the early stages of mild cognitive impairment (MCI) by utilizing imaging and biomarkers. In Japan, J-ADNI enrolled and followed up 537 patients, mainly with MCI, and established a platform for evaluation including amyloid PET, and demonstrated a high similarity in the clinical course of amyloid-positive MCI (prodromal AD) in Japan and the U.S. In 2023, the anti-Aβ antibody lecanemab successfully completed a Phase III clinical trial for early AD (prodromal AD + mild AD dementia) and was granted regulatory approval and made available both in the US and Japan. Also, phase III trial of donanemab was completed successful. The J-TRC study was initiated in Japan as a \"trial ready cohort (TRC)\" consisting of participants who met the eligibility criteria for participation in preclinical and prodromal AD trials. Based on such a platform, the development of DMT for AD will progress more rapidly in the future.</p>","PeriodicalId":20938,"journal":{"name":"Psychiatry and Clinical Neurosciences","volume":null,"pages":null},"PeriodicalIF":5.0000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11488598/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psychiatry and Clinical Neurosciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pcn.13681","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/6 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
To successfully develop disease-modifying therapies (DMT) against Alzheimer's disease (AD), it is important to target the mild stage of the disease, before the pathological changes progress and dementia symptoms are fully manifested. To this end, the AD Neuroimaging Initiative (ADNI), a large-scale observational study, was initiated in the U.S. with the goal of development of DMT that are effective in the early stages of mild cognitive impairment (MCI) by utilizing imaging and biomarkers. In Japan, J-ADNI enrolled and followed up 537 patients, mainly with MCI, and established a platform for evaluation including amyloid PET, and demonstrated a high similarity in the clinical course of amyloid-positive MCI (prodromal AD) in Japan and the U.S. In 2023, the anti-Aβ antibody lecanemab successfully completed a Phase III clinical trial for early AD (prodromal AD + mild AD dementia) and was granted regulatory approval and made available both in the US and Japan. Also, phase III trial of donanemab was completed successful. The J-TRC study was initiated in Japan as a "trial ready cohort (TRC)" consisting of participants who met the eligibility criteria for participation in preclinical and prodromal AD trials. Based on such a platform, the development of DMT for AD will progress more rapidly in the future.
要成功开发出针对阿尔茨海默病(AD)的疾病改变疗法(DMT),就必须在病理变化进展和痴呆症状完全显现之前,针对疾病的轻度阶段进行治疗。为此,美国发起了一项大规模观察性研究--AD 神经影像学倡议(ADNI),目的是利用影像学和生物标志物,开发在轻度认知障碍(MCI)早期阶段有效的 DMT。2023 年,抗 Aβ 抗体 lecanemab 成功完成了针对早期 AD(前驱 AD + 轻度 AD 痴呆)的 III 期临床试验,并获得监管部门批准,在美国和日本上市。此外,多奈单抗的 III 期临床试验也已顺利完成。J-TRC 研究是作为 "试验准备队列(TRC)"在日本启动的,该队列由符合临床前和前驱 AD 试验参与资格标准的参与者组成。基于这样一个平台,DMT 治疗 AD 的开发在未来将取得更快的进展。
期刊介绍:
PCN (Psychiatry and Clinical Neurosciences)
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Published 12 online issues a year by JSPN
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