No Effect of One-Year Treatment with Indomethacin on Alzheimer's Disease Progression: A Randomized Controlled Trial
No Effect of One-Year Treatment with Indomethacin on Alzheimer's Disease Progression: A Randomized Controlled Trial
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DOI：
10.1371/journal.pone.0001475
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发表时间：
2008-01-23
期刊：
影响因子：
3.7
通讯作者：
Kremer, Berry
中科院分区：
文献类型：
--
作者：
de Jong, Danielle;Jansen, Rene;Kremer, Berry
背景资料。这项研究的目的是确定非选择性非类固醇抗炎药(NSAID)吲哚美辛的治疗是否减缓阿尔茨海默病(AD)患者的认知衰退。方法/主要调查结果。这项双盲、随机、安慰剂对照试验于2000年5月至2005年9月在荷兰的两家医院进行。51例轻、中度AD患者入选本研究。患者在12个月内每天接受100毫克吲哚美辛或安慰剂治疗。此外，所有患者都接受了奥美拉唑治疗。主要的结果测量是治疗一年后在AD评估量表(ADAS-COG)的认知子量表(ADAS-COG)上与基线的变化。次要结果测量包括简易智力状态检查，临床医生对照顾者投入的改变的访谈印象，ADAS的非认知子量表，神经精神病学问卷，以及痴呆症患者日常生活恶化的访谈。在招募参与者方面遇到了相当大的问题，导致研究力度不足。在安慰剂组，25名患者中有19名完成了研究，吲哚美辛组26名患者中有19名完成了研究。消炎痛组的ADAS-COG恶化程度(7.8+/-67.6)小于安慰剂组(9.3+/-10.0)。这一差异(1.5分；CI 24.5-7.5)没有统计学意义，任何次要结果指标也没有统计学意义。结论/意义。关于吲哚美辛减缓AD进展的假说，这项研究的结果是不确定的。试行注册。ClinicalTrials.gov NCT00432081
Background. The objective of this study was to determine whether treatment with the nonselective nonsteroidal anti-inflammatory drug (NSAID) indomethacin slows cognitive decline in patients with Alzheimer's disease (AD). Methodology/Principal Findings. This double-blind, randomized, placebo-controlled trial was conducted between May 2000 and September 2005 in two hospitals in the Netherlands. 51 patients with mild to moderate AD were enrolled into the study. Patients received 100 mg indomethacin or placebo daily for 12 months. Additionally, all patients received omeprazole. The primary outcome measure was the change from baseline after one year of treatment on the cognitive subscale of the AD Assessment Scale (ADAS-cog). Secondary outcome measures included the Mini-Mental State Examination, the Clinician's Interview Based Impression of Change with caregiver input, the noncognitive subscale of the ADAS, the Neuropsychiatric Inventory, and the Interview for Deterioration in Daily life in Dementia. Considerable recruitment problems of participants were encountered, leading to an underpowered study. In the placebo group, 19 out of 25 patients completed the study, and 19 out of 26 patients in the indomethacin group. The deterioration on the ADAS-cog was less in the indomethacin group (7.8 +/- 67.6), than in the placebo group (9.3 +/- 10.0). This difference (1.5 points; CI 24.5-7.5) was not statistically significant, and neither were any of the secondary outcome measures. Conclusions/Significance. The results of this study are inconclusive with respect to the hypothesis that indomethacin slows the progression of AD. Trial Registration. ClinicalTrials.gov NCT00432081