Randomized pilot study of nimesulide treatment in Alzheimer's disease
Randomized pilot study of nimesulide treatment in Alzheimer's disease
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DOI：
10.1212/wnl.58.7.1050
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发表时间：
2002-04-09
期刊：
影响因子：
9.9
通讯作者：
Pasinetti, GM
中科院分区：
文献类型：
--
作者：
Aisen, PS;Schmeidler, J;Pasinetti, GM
背景：非甾体类抗炎药（NSAID）可能对AD的治疗有用。尼美舒利是一种优先抑制环氧合酶-2的NSAID，临床和实验室经验表明，它可能是治疗AD的良好候选药物。方法：本研究旨在探讨尼美舒利治疗AD的临床可行性。40例可能患有AD的患者（其中大多数正在服用胆碱酯酶抑制剂）参加了一项随机、对照、平行组试验，旨在评估尼美舒利的耐受性和短期认知/行为效应。在最初的12周双盲阶段，参与者每天两次口服尼美舒利100 mg或匹配的安慰剂;在第二个12周阶段，所有参与者接受活性药物。那些对药物耐受良好并感觉有益的参与者被邀请继续接受开放标签的尼美舒利治疗。结果如下：与安慰剂相比，尼美舒利短期治疗对认知、临床状态、日常生活活动、情感和行为的总评估分数没有显著影响。超过2年的长期治疗耐受性良好。结论：这些发现支持尼美舒利治疗AD的可行性;疗效评估需要更大规模的长期治疗研究。
Background: Nonsteroidal anti-inflammatory drugs (NSAID) may be useful in the treatment of AD. Clinical and laboratory experience with nimesulide, an NSAID with preferential cyclooxygenase-2 inhibition, suggests that it may be a good candidate for AD therapy. Methods: This pilot study investigated the clinical feasibility of nimesulide treatment in AD. Forty persons with probable AD, most of whom were taking cholinesterase inhibitors, were enrolled in a randomized, controlled, parallel-group trial designed to assess tolerability and short-term cognitive/behavioral effects of nimesulide. In the initial 12-week double-blind phase, participants were treated with nimesulide 100 mg by mouth twice daily or matching placebo; during the second 12-week phase all participants received active drug. Participants who tolerated the drug well and perceived benefit were invited to continue open-label nimesulide treatment. Results: Short-term therapy with nimesulide, compared with placebo, had no significant effect on total assessment scores of measures of cognition, clinical status, activities of daily living, affect, and behavior. Long-term therapy was well tolerated for periods exceeding 2 years. Conclusion: These findings support the feasibility of nimesulide therapy in AD; assessment of efficacy will require a larger, long-term treatment study.