Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, VA Greater Los Angeles Healthcare System, 760 Westwood Plaza RM C8-193, Los Angeles, CA 90024, USA.
Expert Opin Biol Ther. 2011 Jun;11(6):787-98. doi: 10.1517/14712598.2011.578573. Epub 2011 Apr 20.
Alzheimer's disease (AD) is a debilitating neurodegenerative illness affecting over 35 million people worldwide. Solanezumab is a monoclonal antibody that binds to β-amyloid (Aβ), a protein that plays a key role in the pathogenesis of AD. The drug is currently being investigated in Phase III trials as a disease-modifying treatment for AD.
This paper reviews literature on solanezumab that is available in PubMed from 2008 to 2010, other treatment trials in clinicaltrials.gov and published abstracts from conferences. The article also provides a discussion of the early trials of AN1792 and an overview of the immunotherapies currently in development. The authors provide the reader with a critical appraisal of the to-date clinical trial data on solanezumab and its implications for the broader field of immunotherapies for AD.
Solanezumab can neutralize soluble Aβ peptides, which may represent the more neurotoxic of the Aβ species. Phase II findings support the compound's safety, which has been a concern for some Aβ immunotherapies. Cerebrospinal and plasma biomarker changes with solanezumab treatment are encouraging. Results of the ongoing Phase III trials will be instrumental in determining the drug's clinical significance.
阿尔茨海默病（AD）是一种使人虚弱的神经退行性疾病，影响着全球超过 3500 万人。Solanezumab 是一种单克隆抗体，可与β-淀粉样蛋白（Aβ）结合，Aβ 在 AD 的发病机制中起着关键作用。该药物目前正在进行 III 期临床试验，作为 AD 的一种疾病修饰治疗方法。
本文综述了 2008 年至 2010 年在 PubMed 上可获得的有关 Solanezumab 的文献、clinicaltrials.gov 上的其他治疗试验和会议发表的摘要。文章还讨论了 AN1792 的早期试验以及目前正在开发的免疫疗法概述。作者对迄今为止关于 Solanezumab 的临床试验数据进行了批判性评估，并对 AD 的免疫疗法领域产生了影响。
Solanezumab 可以中和可溶性 Aβ 肽，可溶性 Aβ 肽可能代表更具神经毒性的 Aβ 物质。II 期研究结果支持该化合物的安全性，这是一些 Aβ 免疫疗法的关注点。脑脊液和血浆生物标志物的变化与 Solanezumab 治疗令人鼓舞。正在进行的 III 期试验的结果将对确定该药物的临床意义具有重要意义。
