Toulouse University Hospital, Alzheimer's Disease Clinical Research Centre, 170 avenue de Casselardit, Gérontopôle, 31059 Toulouse cedex, INSERM UMR 1027, France.
Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15.
Alzheimer's disease is the leading cause of dementia in the elderly, and there is no disease-modifying therapy yet available. Immunotherapy directed against the β-amyloid peptide may be capable of slowing the rate of disease progression. Gantenerumab is the first fully human anti-β-amyloid monoclonal antibody.
To review the efficacy and safety of immunotherapy drugs and in particular gantenerumab, we used the database MEDLINE. The primary literature on gantenerumab is reviewed in its entirety. We also reviewed the English-language, pre-clinical and clinical trials designed to evaluate the efficacy or/and safety of immunotherapy drugs, from 1999 through 2011. Other Alzheimer's disease-passive immunotherapeutics currently in development, according to www.clinicaltrials.gov, are also discussed.
Gantenerumab appears capable of reducing the cerebral β-amyloid peptide burden in patients with Alzheimer's disease. Its ability to slow disease progression remains uncertain because no clinical data are available at present. The next step will be to investigate whether removal of brain amyloid translates into clinical benefit for patients at doses of gantenerumab that reduce brain amyloid and are well tolerated.
阿尔茨海默病是老年人痴呆的主要原因，目前尚无治疗该病的方法。针对β-淀粉样肽的免疫疗法可能具有减缓疾病进展的作用。Gantenerumab 是第一个完全人源化抗β-淀粉样肽单克隆抗体。
为了评估免疫疗法药物，特别是 gantenerumab 的疗效和安全性，我们使用了 MEDLINE 数据库。对 gantenerumab 的主要文献进行了全面回顾。我们还回顾了 1999 年至 2011 年期间设计用于评估免疫疗法药物疗效或/和安全性的英文、临床前和临床试验。根据 www.clinicaltrials.gov 网站，还讨论了目前正在开发的其他阿尔茨海默病被动免疫疗法。
Gantenerumab 似乎能够降低阿尔茨海默病患者大脑中的β-淀粉样肽负荷。由于目前尚无临床数据，其减缓疾病进展的能力仍不确定。下一步将研究在能够降低脑内淀粉样蛋白且具有良好耐受性的剂量下，脑内淀粉样蛋白的清除是否能为患者带来临床获益。
