Fakouhi T D, Jhee S S, Sramek J J, Benes C, Schwartz P, Hantsburger G, Herting R, Swabb E A, Cutler N R
G.D. Searle Company, Skokie, Illinois, USA.
J Geriatr Psychiatry Neurol. 1995 Oct;8(4):226-30. doi: 10.1177/089198879500800405.
This multicenter study evaluated the efficacy and safety of cycloserine and measured its effects on explicit and implicit memory tests in patients with Alzheimer's disease (AD). Four hundred ten patients with AD, aged 50 years or older, were enrolled in this parallel-group, double-blind, placebo-controlled, randomized trial of 5, 15, or 50 mg cycloserine or placebo twice daily, and 403 entered the double-blind treatment phase. Two hundred sixty-five patients completed the entire 26-week treatment phase. There were no baseline differences among the four treatment groups. Cognitive Drug Research (CDR) efficacy assessments showed no differences between active treatments and placebo from baseline to study weeks 2, 6, 14, or 26. Patients receiving 15 mg of cycloserine improved significantly on one section of an implicit memory test. No differences among treatments were observed for any other assessment scales evaluated. The incidence and severity of adverse events were similar across treatment groups. Cycloserine was well tolerated but did not demonstrate consistent evidence of efficacy during the course of therapy. Higher doses may be necessary to achieve efficacy in the AD population and do not appear to be precluded by the adverse event profile seen in this study.
这项多中心研究评估了环丝氨酸的疗效和安全性，并测定了其对阿尔茨海默病（AD）患者显性和隐性记忆测试的影响。410名年龄在50岁及以上的AD患者参加了这项平行组、双盲、安慰剂对照、随机试验，试验中患者每日两次服用5毫克、15毫克或50毫克环丝氨酸或安慰剂，403名患者进入双盲治疗阶段。265名患者完成了整个26周的治疗阶段。四个治疗组之间在基线时没有差异。认知药物研究（CDR）疗效评估显示，从基线到研究第2、6、14或26周，活性治疗组与安慰剂组之间没有差异。接受15毫克环丝氨酸治疗的患者在一项隐性记忆测试的一个部分中有显著改善。在评估的任何其他量表上，各治疗组之间均未观察到差异。各治疗组不良事件的发生率和严重程度相似。环丝氨酸耐受性良好，但在治疗过程中未显示出一致的疗效证据。在AD人群中可能需要更高剂量才能达到疗效，且本研究中观察到的不良事件情况似乎并未排除这种可能性。
