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

被引：84

作者：

Breitner, John ^{[1
,2
]}

Baker, Laura ^{[1
,2
,3
,4
,13
]}

Drye, Lea ^{[5
,10
]}

Evans, Denis ^{[6
]}

Lyketsos, Constantine ^{[7
]}

Ryan, Laurie ^{[7
,8
]}

Zandi, Peter ^{[4
,5
,9
,10
]}

Baker, Laura ^{[1
,2
,3
,4
,13
]}

Breitner, John ^{[1
,2
]}

Saucedo, Hector Hernandez ^{[5
]}

Anau, Jane ^{[5
]}

Cholerton, Brenna ^{[5
]}

Kramer, Kirise ^{[5
]}

Zandi, Peter ^{[4
,5
,9
,10
]}

Drye, Lea ^{[5
,10
]}

Casper, Anne Shanklin ^{[10
]}

Meinert, Curtis ^{[10
]}

Martin, Barbara ^{[10
]}

Jenkins, Gabrielle ^{[10
]}

McCaffrey, Lee ^{[10
]}

Meinert, Jill ^{[10
]}

Vaidya, Vijay ^{[10
]}

Ahuja, Alka ^{[10
]}

May, Pat ^{[10
]}

Ryan, Laurie ^{[7
,8
]}

Lyketsos, Constantine G. ^{[11
]}

Steinberg, Martin ^{[11
]}

Brandt, Jason ^{[11
]}

Pedroso, Julia J. ^{[11
]}

Bergey, Alyssa ^{[11
]}

Gogel, Carol ^{[11
]}

Smith, Lynn ^{[11
]}

Kraus, Jennifer ^{[11
]}

Stern, Robert A. ^{[12
]}

Green, Robert C. ^{[12
]}

Gavett, Brandon ^{[12
]}

Mwicigi, Jane ^{[12
]}

Baldwin, Lorraine ^{[12
]}

McGowan, Theresa ^{[12
]}

Johnson, Patricia ^{[12
]}

Qiu, Wendy ^{[12
]}

Frederick, Jamie ^{[12
]}

Raghavan, Sumati ^{[12
]}

Rossi, Carol ^{[12
]}

Mandell, Alan ^{[12
]}

Dinizo, Daniella ^{[12
]}

Roth, Mary Tara ^{[12
]}

Porsteinsson, Anton ^{[3
,4
]}

Ismail, M. Saleem ^{[3
,4
]}

Weber, Miriam ^{[3
,4
]}

机构：

[1] Douglas Mental Hlth Univ Inst, Ctr Studies Prevent Alzheimers Dis, Montreal, PQ, Canada

[2] McGill Univ, Montreal, PQ, Canada

[3] Veteran Affairs Puget Sound Hlth Care Syst, Seattle, WA USA

[4] Univ Washington, Sch Med, Seattle, WA USA

[5] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

[6] Rush Presbyterian St Lukes Med Ctr, Chicago, IL 60612 USA

[7] Johns Hopkins Sch Med, Baltimore, MD 60612 USA

[8] NIA, Bethesda, MD 20892 USA

[9] Vet Affairs Puget Sound Hlth Care Syst, Res Grp Resource Ctr Chairmans Off, Seattle, WA USA

[10] NIA, Project Off, Bethesda, MD 20892 USA

[11] Boston Univ, Sch Med, Boston, MA 02118 USA

[12] Univ Rochester, Sch Med, Rochester, NY USA

[13] Sun Hlth Res Inst, Sun City, AZ USA

[14] Roskamp Inst Memory Clin, Tampa, FL USA

来源：

ALZHEIMERS & DEMENTIA | 2013年 / 9卷 / 06期

关键词：

Prevention; Clinical trial; Alzheimer's disease; Nonsteroidal anti-inflammatory drug; Naproxen; Celecoxib; DOUBLE-BLIND; ROFECOXIB; NAPROXEN; PLACEBO; INHIBITION; ASPIRIN; DESIGN; NSAIDS; DRUGS;

D O I：

10.1016/j.jalz.2012.11.012

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Objectives: 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. Methods: 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. Results: 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). Conclusions: 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. 2013 The Alzheimer's Association. All rights reserved.

引用

页码：714 / 723

页数：10

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