McLendon B M, Doraiswamy P M
Department of Pharmacy, Duke University Medical Center, Durham, NC 27710, USA.
J Geriatr Psychiatry Neurol. 1999 Spring;12(1):39-48. doi: 10.1177/089198879901200108.
Regulatory guidelines in the US and Europe generally require that a drug specifically indicated for treating Alzheimer's disease (AD) must demonstrate an effect upon the core manifestations of dementia. Progressive cognitive and functional losses are the cardinal features of AD. In the US, current guidelines require that new AD treatments show effectiveness on performance-based measures of cognition and on clinician-rated global assessments. Improvement in function is also emphasized in the European guidelines. The primary instruments that have been used to evaluate changes in cognition and global function in most recent AD trials are the cognitive subscale of the Alzheimer's Disease Assessment Scale and a version of the Clinician's Interview Based Impression of Change, respectively. The results from three pivotal trials investigating the acetylcholinesterase inhibitor, donepezil, are used to demonstrate the way in which these tools are used, how to interpret the data they provide, and to determine their overall value in ascertaining efficacy in clinical practice.
美国和欧洲的监管指南通常要求，专门用于治疗阿尔茨海默病（AD）的药物必须对痴呆的核心表现产生效果。进行性认知和功能丧失是AD的主要特征。在美国，现行指南要求新的AD治疗方法在基于表现的认知测量和临床医生评定的整体评估方面显示出有效性。欧洲指南也强调功能的改善。在最近的AD试验中，用于评估认知和整体功能变化的主要工具分别是阿尔茨海默病评估量表的认知子量表和临床医生基于访谈的变化印象的一个版本。三项研究乙酰胆碱酯酶抑制剂多奈哌齐的关键试验结果用于说明这些工具的使用方式、如何解释它们提供的数据，以及确定它们在临床实践中确定疗效方面的总体价值。
