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)