中国阿尔茨海默病新药在美启动国际3期临床试验

2020-11-07 新华网 新华网

2020年第13届阿尔茨海默病临床试验大会4日至7日在线召开。开幕当天,美国克利夫兰医学中心教授、甘露特钠胶囊国际多中心3期临床试验方案主导设计者兼首席科学家杰弗里·卡明斯在会议上表示,

2020年第13届阿尔茨海默病临床试验大会4日至7日在线召开。开幕当天,美国克利夫兰医学中心教授、甘露特钠胶囊国际多中心3期临床试验方案主导设计者兼首席科学家杰弗里·卡明斯在会议上表示,甘露特钠胶囊已在位于美国纽约州锡拉丘兹市的克拉里蒂临床研究中心顺利完成第一例患者筛查

据卡明斯介绍,入组患者将进行为期52周的多中心随机、双盲双臂、平行组安慰剂对照、单药疗法临床试验。在双盲期之后,还将开展为期26周的开放试验。根据计划,未来6个月将招募五分之一的临床试验患者。

这一国际3期临床试验将涉及14个国家、2046名轻度至中度阿尔茨海默病患者,来自中国的患者占40%,来自北美和欧洲的患者数量各占30%。

卡明斯说,相较于此前在中国开展的3期临床试验,此次国际临床试验设计将双盲试验周期从9个月延长到了12个月,有助于进一步验证甘露特钠胶囊对于患者认知功能改善的药效持续性。

美国食品药品管理局今年4月3日批准甘露特钠胶囊的研发企业上海绿谷制药有限公司开展该药的国际多中心3期临床试验。

甘露特钠胶囊在中国已完成3期临床试验,2019年在中国被有条件批准上市,用于治疗轻度至中度阿尔茨海默病患者。

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