Function and clinical meaningfulness of treatments for mild Alzheimer's disease.
Function and clinical meaningfulness of treatments for mild Alzheimer's disease.
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DOI：
10.1016/j.dadm.2016.02.006
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Liu-Seifert H
中科院分区：
文献类型：
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作者：
Siemers E;Holdridge KC;Sundell KL;Liu-Seifert H
阿尔茨海默病(AD)治疗的有效性通常通过共同的结果来评估；认知与功能相结合，以确保认知效果的临床意义。我们回顾了使用批准的AD药物治疗轻度AD或轻度认知障碍(MCI)患者(与轻度-中度/重度合并AD不同)的功能结果的文献。在Solanezumab探险/ExPEDITIO2研究中，比较了轻度AD患者的认知和功能治疗随时间的差异。有7篇文章提供了MCI/轻度AD的功能结果，其中一篇报道了显著的功能治疗效果。对探险研究的二次分析表明，Solanezumab相对于认知功能的影响较小。在18个月以上的时间里，solane zumab对认知和功能有增强作用。功能作为证明轻度阿尔茨海默病认知效应临床意义的唯一指标可能有局限性。对于疾病调节治疗，认知和功能量表上的点数差异应该与治疗持续时间相一致。
Effectiveness of Alzheimer's disease (AD) treatments is commonly evaluated with coprimary outcomes; cognition with function to ensure clinical meaningfulness of a cognitive effect. We reviewed the literature for functional outcomes in mild AD or mild cognitive impairment (MCI) patients (distinct from combined mild-moderate/severe AD) treated with approved AD drugs. Cognitive and functional treatment differences in mild AD patients in solanezumab EXPEDITION/EXPEDITION2 studies were compared across time. Seven publications provided MCI/mild AD functional outcomes, one of which reported a significant functional treatment effect. Secondary analyses of EXPEDITION studies suggested a smaller functional effect of solanezumab relative to cognition. An increasing effect of solanezumab over 18 months was shown for cognition and function. Function as the sole measure to demonstrate clinical meaningfulness of cognitive effects in mild AD may have limitations. For disease-modifying treatments, point differences on cognitive and functional scales should be qualified with duration of treatment.