Pasquier F
Centre de la Mémoire, Clinique Neurologique, CHRU 59037 Lille, France.
Therapie. 2000 Jul-Aug;55(4):513-9.
Memory assessment in pharmaceutical trials has to date been mainly performed in Alzheimer's disease. North American and European Medical Evaluating Agencies recommend guidelines. Tests need to be simple and short, and sensitive enough to assess changes over a wide range of severity to avoid floor or ceiling effect. They require inter-rater reliability and face validity. They should be at least appropriate for different languages and culture, correlate well with universally accepted estimates of a function and have several parallel forms available to avoid a training effect. Memory is assessed with sub-tests of composite scales assessing a number of cognitive functions including episodic memory. The ADAS-Cog has become the standard instrument since it was used for the approval of tacrine and other cholinesterase inhibitors. Some studies have assessed more specifically different sub-systems of memory. However, autobiographical, remote or prospective memory, as well as metamemory, has not been explored in pharmaceutical trials.
迄今为止，药物试验中的记忆评估主要在阿尔茨海默病患者中进行。北美和欧洲医学评估机构推荐了相关指南。测试需要简单、耗时短，并且足够灵敏，以评估广泛严重程度范围内的变化，避免出现地板效应或天花板效应。它们需要评定者间信度和表面效度。它们至少应适用于不同语言和文化，与普遍接受的功能评估结果具有良好的相关性，并且有多种平行版本可供使用，以避免训练效应。通过综合量表的子测试来评估记忆，这些量表用于评估包括情景记忆在内的多种认知功能。自他克林和其他胆碱酯酶抑制剂获批以来，ADAS - Cog已成为标准工具。一些研究更具体地评估了不同的记忆子系统。然而，自传体记忆、远期记忆或前瞻性记忆以及元记忆在药物试验中尚未得到探索。
