Cognitive function over time in the Alzheimer's disease anti-inflammatory prevention trial (ADAPT) - Results of a randomized, controlled trial of naproxen and celecoxib
Cognitive function over time in the Alzheimer's disease anti-inflammatory prevention trial (ADAPT) - Results of a randomized, controlled trial of naproxen and celecoxib
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DOI：
10.1001/archneur.2008.65.7.nct70006
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发表时间：
2008-07-01
影响因子：
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通讯作者：
Mullan, Michael
中科院分区：
文献类型：
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作者：
Martin, Barbara K.;Szekely, Christine;Mullan, Michael
背景：观察性研究表明，非甾体抗炎药使用者患阿尔茨海默氏痴呆的风险降低。目的：评估萘普生钠和塞来昔布对老年人认知功能的影响。设计：随机、双盲化学预防试验。地点：美国六家记忆诊所。参与者：70 岁及以上有阿尔茨海默病家族史的男性和女性； 2528 名受试者中的 2117 名进行了后续认知评估。干预措施：塞来昔布（200 毫克，每天两次）、萘普生钠（220 毫克，每天两次）或安慰剂，分别以 1:1:1.5 的比例随机分配。主要结果指标：每年测量 7 项认知功能测试和总体总结评分。结果：纵向分析显示，随着时间的推移，总体总结评分较低与安慰剂相比，萘普生的得分较低（- 0.05 SD；P=. 02），并且与安慰剂相比，两个治疗组随时间推移的改良简易精神状态检查得分较低（塞来昔布为 - 0.33 分 [ P=. 04]，萘普生为 - 0.36 分 [ P=. 02]）。对从非痴呆症患者收集的测量值进行分析的限制削弱了治疗组的差异。仅限于参与者服用研究药物时获得的测量结果的分析产生了与意向治疗分析相似的结果。结论：使用萘普生或塞来昔布并没有改善认知功能。有微弱的证据表明萘普生具有有害作用。试验注册：临床试验。政府标识符：NCT00007189
Background: Observational studies have shown reduced risk of Alzheimer dementia in users of nonsteroidal anti-inflammatory drugs.Objective: To evaluate the effects of naproxen sodium and celecoxib on cognitive function in older adults.Design: Randomized, double-masked chemoprevention trial.Setting: Six US memory clinics.Participants: Men and women aged 70 years and older with a family history of Alzheimer disease; 2117 of 2528 enrolled had follow-up cognitive assessment.Interventions: Celecoxib ( 200mgtwice daily), naproxen sodium ( 220 mg twice daily), or placebo, randomly allocated in a ratio of 1: 1: 1.5, respectively.Main Outcome Measures: Seven tests of cognitive function and a global summary score measured annually.Results: Longitudinal analyses showed lower global summary scores over time for naproxen compared with placebo (- 0.05 SDs; P=. 02) and lower scores on the Modified Mini- Mental State Examination over time for both treatment groups compared with placebo (- 0.33 points for celecoxib [ P=. 04] and - 0.36 points for naproxen [ P=. 02]). Restriction of analyses to measures collected from persons without dementia attenuated the treatment group differences. Analyses limited to measures obtained while participants were being issued study drugs produced results similar to the intention- to- treat analyses.Conclusions: Use of naproxen or celecoxib did not improve cognitive function. There was weak evidence for a detrimental effect of naproxen.Trial Registration: clinicaltrials. gov identifier: NCT00007189