NEJM:Donanemab治疗早期阿尔茨海默病临床研究获得积极结果

2021-05-06 MedSci原创 MedSci原创

在早期阿尔茨海默病患者中, donanemab治疗在改善认知能力和日常生活活动能力方面优于安慰剂,PET-CT显示,donanemab治疗后患者淀粉样斑块水平和整体tau负荷下降

大脑中淀粉样蛋白β(Aβ)累积是阿尔茨海默病(AD)的主要神经病理学特征,可导致神经退行性变,认知和功能损伤。在AD早期,患者多表现为轻度认知障碍,随着淀粉样斑块的积累,直至发展到痴呆。AD的另一个神经病理学特征是高磷酸化tau蛋白神经原纤维缠结。模型研究表明,Aβ可触发tau蛋白磷酸化,Aβ和tau蛋白之间复杂,协同地相互作用导致阿尔茨海默病的进展。Donanemab可靶向N3pGβ淀粉样蛋白,先前的研究中,通过淀粉样蛋白成像测量证实,其可迅速清除淀粉样蛋白斑块。近日研究人员公布了donanemab的II期临床研究结果

经PET-CT证实的tau蛋白和淀粉样蛋白沉积阳性的早期症状性阿尔茨海默病患者参与研究,随机每4周静脉注射一次donanemab(前三次700mg,最后一次1400mg)或安慰剂,持续72周。研究的主要结果是综合阿尔茨海默病评定量表(iADRS,范围0-144,分数越低表示认知和功能损害越严重)得分较基线的变化。次要结果包括临床痴呆评定量表(CDR-SB)得分、13项阿尔茨海默病评定量表(ADAS-Cog13)认知子量表得分、阿尔茨海默病合作研究-日常生活工具活动量表(ADCS-iADL)得分,以及微型精神状态检查(MMSE),以及PET显示的淀粉样蛋白和tau负荷变化。

257名患者参与研究,其中131人接受donanemab治疗,126人接受安慰剂。两组的基础iADRS评分均为106分。与基线检查时相比,76周时iADRS评分的变化如下:donanemab组为-6.86分,而安慰剂组为-10.06分(差异3.20)。组间大多数次要结果无实质性差异。但76周时,与安慰剂组相比,donanemab组淀粉样斑块水平下降了85.06个centiloids单位,整体tau负荷下降了0.01。donanemab组出现淀粉样蛋白相关的脑水肿或渗出风险较高,但多数无症状。

主要,次要终点比较

影像学结果比较

在早期阿尔茨海默病患者中, donanemab治疗在改善认知能力和日常生活活动能力方面优于安慰剂,PET-CT显示,donanemab治疗后患者淀粉样斑块水平和整体tau负荷下降

原始出处:

Mark A. Mintun et al. Donanemab in Early Alzheimer's Disease. N Engl J Med, May 06, 2021.

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    2021-09-15 智智灵药
  4. [GetPortalCommentsPageByObjectIdResponse(id=1817080, encodeId=12fe181e080e9, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Apr 16 00:30:24 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818103, encodeId=69e9181810303, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=636e2500187, createdName=12498da4m32(暂无昵称), createdTime=Thu Jun 17 18:30:24 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912594, encodeId=105419125941c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Sep 15 05:30:24 CST 2021, time=2021-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317631, encodeId=646e131e63152, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sat May 08 08:30:24 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470457, encodeId=cd8e14e04575a, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sat May 08 08:30:24 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035637, encodeId=0afc103563e02, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu May 06 20:30:24 CST 2021, time=2021-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=963187, encodeId=167f96318ed8, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Thu May 06 19:52:30 CST 2021, time=2021-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=963143, encodeId=cd059631430f, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Thu May 06 17:36:23 CST 2021, time=2021-05-06, status=1, ipAttribution=)]
    2021-05-08 fengyi812
  5. [GetPortalCommentsPageByObjectIdResponse(id=1817080, encodeId=12fe181e080e9, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Apr 16 00:30:24 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818103, encodeId=69e9181810303, content=<a href='/topic/show?id=4c9f9e777ac' target=_blank style='color:#2F92EE;'>#阿尔茨海#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97777, encryptionId=4c9f9e777ac, topicName=阿尔茨海)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=636e2500187, createdName=12498da4m32(暂无昵称), createdTime=Thu Jun 17 18:30:24 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912594, encodeId=105419125941c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Sep 15 05:30:24 CST 2021, time=2021-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317631, encodeId=646e131e63152, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sat May 08 08:30:24 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470457, encodeId=cd8e14e04575a, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Sat May 08 08:30:24 CST 2021, time=2021-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035637, encodeId=0afc103563e02, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu May 06 20:30:24 CST 2021, time=2021-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=963187, encodeId=167f96318ed8, content=好文章!, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160806/IMG57A5698BDB0244113.jpg, createdBy=32a91358059, createdName=jyzxjiangqin, createdTime=Thu May 06 19:52:30 CST 2021, time=2021-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=963143, encodeId=cd059631430f, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Thu May 06 17:36:23 CST 2021, time=2021-05-06, status=1, ipAttribution=)]
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    2021-05-06 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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    2021-05-06 jyzxjiangqin

    好文章!

    0

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    2021-05-06 医鸣惊人

    认真学习了

    0

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