Results of a follow-up study to the randomized Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT).

Results of a follow-up study to the randomized Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT).
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DOI:
10.1016/j.jalz.2012.11.012
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发表时间:
2013-11
期刊:
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子:
--
通讯作者:
Alzheimer's Disease Anti-inflammatory Prevention Trial Research Group
Alzheimer's Disease Anti-inflammatory Prevention Trial Research Group
中科院分区:
其他
文献类型:
--
作者:
Alzheimer's Disease Anti-inflammatory Prevention Trial Research Group

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阿尔茨海默病抗炎预防试验随访研究(ADAPT- fs)旨在评估萘普生和塞来昔布在停止治疗几年后对阿尔茨海默病(AD)一级预防的疗效。ADAPT是一项随机、双盲、多中心临床试验,在美国6家诊所进行萘普生或塞来昔布与安慰剂(1:1:1.5分配比)的比较。该试验在2001年至2004年间招募了2528人。治疗于2004年12月停止,参与者在2007年之前接受定期监测。在2010年和2011年,ADAPT-FS通过电话筛选了1537名参与者,如果有需要,则使用标准化临床评估亲自对他们进行检查。主要观察指标为诊断AD的时间。对未定位的参与者进行死亡索引搜索。在ADAPT- fs和ADAPT- fs中,共发现89个AD事件(塞来昔布24个,萘普生25个,安慰剂40个),共161个事件(塞来昔布48个[6.6%],萘普生43个[6.0%],安慰剂70个[6.5%])。调整后的风险比(HR)比较各治疗与安慰剂均未显示AD的总体风险降低:塞来昔布与安慰剂的HR为1.03(95%可信区间[CI], 0.72-1.50; P = 0.86);萘普生与安慰剂的HR, 0.92 (95% CI, 0.62 - 1.35; P = 0.66)。349例死亡(塞来昔布110例[15.2%],萘普生96例[13.4%],安慰剂143例[13.2%])。与安慰剂组相比,萘普生组和安慰剂组的死亡风险相似(HR, 0.99; 95% CI, 0.76 - 1.28; P = 0.93),塞来昔布组的死亡风险略高于安慰剂组(HR, 1.15; 95% CI, 0.90 - 1.48; P = 0.27)。在大约7年的随访中获得的这些结果(其中包括中位数不到1.5年的治疗)不支持塞来昔布或萘普生预防有痴呆家族史的成人AD的假设。
The Alzheimer's Disease Anti-inflammatory Prevention Trial Follow-up Study (ADAPT-FS) was designed to evaluate the efficacy of naproxen and celecoxib for the primary prevention of Alzheimer's disease (AD) several years after cessation of treatment in ADAPT. ADAPT was a randomized, double-masked, multicenter clinical trial of naproxen or celecoxib vs placebo (1:1:1.5 assignment ratio) at six U.S.-based clinics. The trial enrolled 2528 people between 2001 and 2004. Treatments were discontinued in December 2004 and participants were monitored regularly until 2007. In 2010 and 2011, ADAPT-FS screened 1537 participants by telephone and, if indicated, examined them in person using standardized clinical assessments. The primary outcome was time to diagnosis of AD. Death index searches were performed for participants not located. Eighty-nine additional AD events were identified (24 celecoxib, 25 naproxen, and 40 placebo) yielding a total of 161 events (48 [6.6% of randomized participants] celecoxib, 43 [6.0%] naproxen, and 70 [6.5%] placebo) across ADAPT and ADAPT-FS. Adjusted hazard ratios (HRs) comparing each treatment with placebo showed no overall reduction in risk of AD: HR celecoxib vs placebo, 1.03 (95% confidence interval [CI], 0.72–1.50; P = .86); HR naproxen vs placebo, 0.92 (95% CI, 0.62– 1.35; P = .66). There were 349 deaths (110 [15.2%] celecoxib, 96 [13.4%] naproxen, and 143 [13.2%] placebo). Risk of death was similar for the naproxen- and placebo-assigned groups (HR, 0.99; 95% CI, 0.76−1.28; P = .93) and slightly higher for celecoxib compared with the placebo-assigned group (HR, 1.15; 95% CI, 0.90−1.48; P = .27). These results acquired during a follow-up of approximately 7 years (which included a median of less than 1.5 years of treatment) do not support the hypothesis that celecoxib or naproxen prevent AD in adults with a family history of dementia.
DOI: 10.1212/wnl.62.1.66
发表时间: 2004-01-13
期刊: NEUROLOGY
影响因子: 9.9
作者:
Reines, SA;Block, GA;Baranak, CC
通讯作者: Baranak, CC
DOI: 10.1016/j.jalz.2010.12.014
发表时间: 2011-07
期刊: Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子: --
作者:
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通讯作者: ADAPT Research Group
DOI: 10.1038/35102591
发表时间: 2001-11-08
期刊: NATURE
影响因子: 64.8
作者:
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通讯作者: Koo, EH
DOI: 10.1016/s0197-2456(01)00189-1
发表时间: 2002-02-01
期刊: CONTROLLED CLINICAL TRIALS
影响因子: --
作者:
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通讯作者: Breitner, JCS
DOI: 10.1001/archneur.2008.65.7.nct70006
发表时间: 2008-07-01
影响因子: --
作者:
Martin, Barbara K.;Szekely, Christine;Mullan, Michael
通讯作者: Mullan, Michael