Masitinib作为辅助治疗轻度到中度阿尔茨海默氏症:一项随机,安慰剂对照第二阶段试验。

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移液管F, Belmin J,文森特·H,施密特N, Pariel年代,Verny M,侯爵C,这位母亲J, Hugonot-Diener L,其JP, Dubreuil P, Moussy, Hermine O

Masitinib作为辅助治疗轻度到中度阿尔茨海默氏症:一项随机,安慰剂对照第二阶段试验。

老年痴呆症Res。2011年4月19日;3 (2):16。doi: 10.1186 / alzrt75。

PubMed ID

21504563 (在PubMed

]

文摘

作品简介:神经炎症被认为是重要的阿尔茨海默病发病机理。肥大细胞是炎症网络的关键组成部分,参与血脑屏障的通透性的调节。Masitinib,选择性口服酪氨酸激酶抑制剂,有效地抑制了生存,肥大细胞的迁移和活动。大脑是丰富的肥大细胞,治疗的潜力masitinib作为标准治疗的辅助疗法进行了研究。方法:随机、安慰剂对照,第二阶段研究了轻度到中度阿尔茨海默氏症患者,接受masitinib作为兼职胆碱酯酶抑制剂和/或美金刚胺。病人被随机分配接受masitinib (n = 26)(起始剂量的3或6毫克/公斤/天)或安慰剂(n = 8),管理每天两次24周。主要终点是改变基线在阿尔茨海默病评定量表-认知子量表(ADAS-Cog)评估认知功能和相关病人反应率。结果:临床相关的认知能力下降的速度根据ADAS-Cog响应(增加> 4分)12和24周后显著降低了masitinib辅助治疗与安慰剂相比(6%比50%的时间点;分别为P = 0.040, P = 0.046)。此外,而安慰剂治疗手臂显示恶化意味着ADAS-Cog,阿尔茨海默病合作研究日常生活活动量表,细微精神状态检查和分数,masitinib治疗手臂报道改进,之间有统计学意义治疗在第12周的武器和/或星期24(分别P = 0.016和0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events were of mild or moderate intensity and transitory. Severe adverse events occurred at a similar frequency in the masitinib and placebo arms (15% vs. 13% of patients, respectively). Masitinib-associated events included gastrointestinal disorders, oedema, and rash. CONCLUSIONS: Masitinib administered as add-on therapy to standard care during 24 weeks was associated with slower cognitive decline in Alzheimer's disease, with an acceptable tolerance profile. Masitinib may therefore represent an innovative avenue of treatment in Alzheimer's disease. This trial provides evidence that may support a larger placebo-controlled investigation. TRIAL REGISTRATION: Clinicaltrials.gov NCT00976118.

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药物

Masitinib