Clinical trial design issues in mild to moderate Alzheimer disease.
Clinical trial design issues in mild to moderate Alzheimer disease.
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DOI：
10.1097/wnn.0b013e318190cf75
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发表时间：
2008-12
期刊：
影响因子：
--
通讯作者：
Knopman DS
中科院分区：
文献类型：
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作者：
Knopman DS
阿尔茨海默病（AD）的临床试验和治疗领域只有20多年的历史。在为AD的有前途的治疗药物的临床试验设计适当的设计方面已经取得了相当大的进展。本文就诊断标准、结果指标的选择、试验持续时间和分析策略等方面的基本问题进行综述。通过反复试验，已经形成了一套通用策略，用于评估轻度至中度AD的推定疗法。过去二十年的经验为发现下一代抗AD药物并在疾病的温和阶段引入这些疗法奠定了基础。
The field of clinical trials and therapeutics in Alzheimer Disease (AD) is little more than 20 years old. Considerable progress has been made in crafting appropriate designs for clinical trials of promising therapeutic agents for AD. This article reviews basic issues in diagnostic criteria, choice of outcome measures, duration of trials and analytic strategies. Through trial and error, a general set of strategies has evolved for the assessment of putative therapies for mild to moderate AD. The experience of the past two decades has set the stage for discovering the next generation of anti-AD drugs and introducing those therapies at milder stages of the disease.