Freedman M, Rewilak D, Xerri T, Cohen S, Gordon A S, Shandling M, Logan A G
Behavioural Neurology Program and Rotman Research Institute, Baycrest Centre for Geriatric Care, North York, Ontario, Canada.
Neurology. 1998 Mar;50(3):660-8. doi: 10.1212/wnl.50.3.660.
Short-term studies of L-deprenyl in Alzheimer's disease (AD) suggest a beneficial effect, whereas longer-term studies are less convincing. Accordingly, we undertook a 6-month, randomized, double-blind, placebo-controlled clinical trial to assess the potential benefit of L-deprenyl in AD.
Sixty subjects were assigned to L-deprenyl (10 mg daily) or placebo. After 4 weeks of single-blind placebo, 51 subjects entered the double-blind phase. The Brief Psychiatric Rating Scale (BPRS) was the primary outcome measure. Secondary outcome measures were the Mini-Mental State Examination, Global Deterioration Scale, Alzheimer's Disease Assessment Scale (noncognitive), Cornell Scale for Depression in Dementia, Buschke Selective Reminding Test (BSRT), Relative's Assessment of Global Symptomatology-Elderly (RAGS-E), Controlled Oral Word Association Test, and Modified Continuous Performance Test. In addition, several exploratory tasks were included for future hypothesis testing.
We found no significant differences between the L-deprenyl and placebo groups on the primary or secondary measures. However, several measures appeared to be sensitive to change over time, including the total score on the BPRS and some of its components as well as parts of the BSRT and the RAGS-E.
Oral L-deprenyl provides no detectable benefit on general behavior, neuropsychiatric symptoms, or cognitive function in AD after 6 months of treatment. Protocols for future drug studies should utilize measures that are sensitive to change over time such as the BPRS.
左旋司来吉兰治疗阿尔茨海默病(AD)的短期研究显示出有益效果,而长期研究的说服力则较弱。因此,我们开展了一项为期6个月的随机、双盲、安慰剂对照临床试验,以评估左旋司来吉兰在AD中的潜在益处。
60名受试者被分配至左旋司来吉兰组(每日10毫克)或安慰剂组。经过4周的单盲安慰剂治疗后,51名受试者进入双盲阶段。简明精神病评定量表(BPRS)是主要结局指标。次要结局指标包括简易精神状态检查表、总体衰退量表、阿尔茨海默病评估量表(非认知部分)、痴呆抑郁康奈尔量表、布施克选择性提醒测验(BSRT)、亲属对总体症状的评估-老年人版(RAGS-E)、受控口语联想测验和改良持续操作测验。此外,还纳入了一些探索性任务以供未来进行假设检验。
我们发现左旋司来吉兰组和安慰剂组在主要或次要指标上均无显著差异。然而,一些指标似乎对随时间的变化较为敏感,包括BPRS总分及其某些分量表,以及BSRT和RAGS-E的部分内容。
治疗6个月后,口服左旋司来吉兰对AD患者的一般行为、神经精神症状或认知功能未显示出可检测到的益处。未来药物研究方案应采用对随时间变化敏感的指标,如BPRS。