Cutler N R, Fakouhi T D, Smith W T, Hendrie H C, Matsuo F, Sramek J J, Herting R L
California Clinical Trials, Beverly Hills 90211.
J Geriatr Psychiatry Neurol. 1993 Apr-Jun;6(2):115-9. doi: 10.1177/089198879300600210.
A multicenter, double-blind, placebo-controlled, parallel group study was conducted to assess the safety and efficacy of three doses of milacemide in the treatment of patients with senile dementia of the Alzheimer type of mild to moderate severity. Patients were randomly assigned to receive one of three dosages of milacemide (400, 800, or 1200 mg/day) or placebo for 4 weeks followed by a single-blind 4-week placebo period. One hundred forty-eight men and women older than 50 years of age were enrolled, and 129 patients completed the study. The differences among treatment groups were not statistically different with respect to total scores on the Alzheimer's Disease Assessment Scale or any items and subscales that were examined, nor were significant differences on the Clinical Global Impression Scale found. Clinically significant increases in liver function tests, specifically aspartate aminotransferase and alanine aminotransferase (AST and ALT), were reported for five of the patients receiving milacemide, requiring their withdrawal from the study.
开展了一项多中心、双盲、安慰剂对照、平行组研究，以评估三种剂量的米拉醋胺治疗轻度至中度阿尔茨海默型老年痴呆症患者的安全性和疗效。患者被随机分配接受三种剂量的米拉醋胺（400、800或1200毫克/天）之一或安慰剂，为期4周，随后是为期4周的单盲安慰剂期。招募了148名年龄超过50岁的男性和女性，129名患者完成了研究。在阿尔茨海默病评估量表的总分或所检查的任何项目和子量表方面，治疗组之间的差异无统计学意义，在临床总体印象量表上也未发现显著差异。接受米拉醋胺治疗的5名患者报告肝功能检查出现临床显著升高，特别是天冬氨酸转氨酶和丙氨酸转氨酶（AST和ALT），这要求他们退出研究。
