Allain H, Belliard S, Lieury A, Menard G, Patat A, Le Coz F, Gandon J M
Laboratoire de Pharmacologie Expérimentale et Clinique, Faculté de Médecine, Rennes, France.
Therapie. 1996 Mar-Apr;51(2):155-62.
Thirty five subjects (age: 45-69 years) with subjective memory loss, without any other neuropsychiatric or somatic disease, were recruited in a phase II study. This double blind randomized versus placebo controlled study compared the effects of minaprine (200 mg/d) with placebo, in two parallel groups, during 2 months, on memory, attention and vigilance. Three psychometric tests were the main criteria of assessment: a standardized battery of memory tests (SM 5), the dual-coding test, the analysis of choice reaction times (CRT) and the critical flicker fusion point (CFF). A positive effect of minaprine was detected on words delayed recall (p = 0.028) and immediate recognition of words (p = 0.049). The global clinical tests (CGI, MacNair scale) were not statistically modified. Tolerability of minaprine and placebo were comparable. A positive pharmacodynamic activity on mnemonic performance is thus demonstrated in favour of minaprine (200 mg/d) in this specific population characterized by a memory complaint. These results would lead to a phase III study in which the main criteria would be global scales in order to confirm the clinical reliability of the present results.
35名主观记忆减退、无其他神经精神或躯体疾病的受试者（年龄：45 - 69岁）被纳入一项II期研究。这项双盲随机对照安慰剂研究在两个月内，将两个平行组中米那普明（200毫克/天）与安慰剂的效果进行比较，观察对记忆、注意力和警觉性的影响。三项心理测量测试为主要评估标准：一组标准化记忆测试（SM 5）、双重编码测试、选择反应时间（CRT）分析和临界闪烁融合点（CFF）。在单词延迟回忆（p = 0.028）和单词即时识别（p = 0.049）方面检测到米那普明有积极作用。整体临床测试（CGI，麦克奈尔量表）无统计学改变。米那普明和安慰剂的耐受性相当。因此，在这个以记忆障碍为特征的特定人群中，已证明米那普明（200毫克/天）对记忆表现有积极的药效学活性。这些结果将促成一项III期研究，其中主要标准将是整体量表，以确认当前结果的临床可靠性。
