Homma A
Department of Psychiatry, Tokyo Metropolitan Institute of Gerontology.
Nihon Ronen Igakkai Zasshi. 1992 Apr;29(4):264-70.
Recently more than a dozen clinical trials for dementia of the Alzheimer type (DAT) have been conducted in Japan using almost the same diagnostic criteria and assessment procedures. Cholinomimetic drugs such as AChE or M1 agonist are the most common in the current clinical drug trials. DSM-IIIR and NINCDS-ADRDA are usually employed as diagnostic criteria. In the recent report on the sensitivity and specificity of these diagnostic criteria, it has been indicated that the clinician or researcher who wishes to ensure that patients classified as DAT are more likely DAT should choose DSM-III, whereas the investigator who wishes to include the greatest number or DAT cases, seldom assigning a diagnosis of no DAT to a true case, should choose NINCDS-ADRAD. Also, development of exclusion criteria for DAT would be essential to improve interrater reliability of these diagnostic criteria. In the recent clinical trials outside Japan, a dual assessment procedure consisting of objective psychometric test(s) to assess cognitive impairment and global clinical impression of change is a standard method to evaluate the clinical efficacy of drugs for DAT. In psychometric tests, Alzheimer's Disease Assessment Scale (ADAS) is the most common in the US and Hasegawa's Dementia Scale (HDS) in Japan. A Japanese version of ADAS-cog. has been already developed for use in clinical trials in Japan. Also, HDS has recently been revised to improve the sensitivity of the test. In addition, Clinical Dementia Rating (CDR) that is one of the common measures staging severity of dementia in Japan might be a better alternative to the conventional Clinical Global Impression of Change (CGIC) in the US.(ABSTRACT TRUNCATED AT 250 WORDS)
最近,日本进行了十几项针对阿尔茨海默型痴呆(DAT)的临床试验,采用了几乎相同的诊断标准和评估程序。胆碱模拟药物如乙酰胆碱酯酶(AChE)或M1激动剂是当前临床药物试验中最常用的药物。DSM-IIIR和NINCDS-ADRDA通常被用作诊断标准。在最近关于这些诊断标准敏感性和特异性的报告中指出,希望确保被归类为DAT的患者更可能患有DAT的临床医生或研究人员应选择DSM-III,而希望纳入最多DAT病例、很少将无DAT诊断分配给真正病例的研究人员应选择NINCDS-ADRAD。此外,制定DAT的排除标准对于提高这些诊断标准的评分者间可靠性至关重要。在日本以外地区最近的临床试验中,由评估认知障碍的客观心理测量测试和整体临床变化印象组成的双重评估程序是评估DAT药物临床疗效的标准方法。在心理测量测试中,美国最常用的是阿尔茨海默病评估量表(ADAS),日本则是长谷川痴呆量表(HDS)。ADAS-cog的日语版本已经开发出来用于日本的临床试验。此外,HDS最近也进行了修订以提高测试的敏感性。此外,作为日本常用的痴呆严重程度分期指标之一的临床痴呆评定量表(CDR),可能比美国传统的临床总体变化印象量表(CGIC)更具优势。(摘要截选至250词)