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Cited by 402Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsInflammatory mediators and NSAID effects

The DOI matches its Crossref record; 51 of the 51 references it cites were found in a registry or an index.

A Randomized, Double-Blind, Study of Rofecoxib in Patients with Mild Cognitive Impairment

on behalf of the Rofecoxib Protocol 078 study group, Thal, Leon J, Ferris, Steven H, Kirby, Louis, Block, Gilbert A, Lines, Christopher R, Yuen, Eric, Assaid, Christopher, Nessly, Michael L, Norman, Barbara A, Baranak, Christine C, Reines, Scott A·2005·Neuropsychopharmacology
DOI 10.1038/sj.npp.1300690
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Abstract

Inflammatory mechanisms have been implicated in Alzheimer's disease (AD) and might be mediated via the COX-2 enzyme. Previous studies with the selective COX-2 inhibitors, rofecoxib and celecoxib, have shown that they do not alter the progression of AD. We conducted a double-blind study to investigate whether rofecoxib could delay a diagnosis of AD in patients with mild cognitive impairment (MCI), a group with an expected annual AD diagnosis rate of 10-15%. MCI patients > or =65 years were randomized to rofecoxib 25 mg (N=725) or placebo (N=732) daily for up to 4 years. The primary end point was the percentage of patients with a clinical diagnosis of AD. The estimated annual AD diagnosis rate was lower than the anticipated 10-15%: 6.4% in the rofecoxib group vs 4.5% in the placebo group (rofecoxib : placebo hazard ratio=1.46 (95% CI: 1.09, 1.94), p=0.011). Analyses of secondary end points, including measures of cognition (eg the cognitive subscale of the AD Assessment Scale (ADAS-Cog)) and global function (eg the Clinical Dementia Rating (CDR)), did not demonstrate differences between treatment groups. There was also no consistent evidence that rofecoxib differed from placebo in post hoc analyses comparing ADAS-Cog and CDR-sum of boxes scores in overlapping subgroups of patients who had Mini Mental State Exam scores of 24-26 in the present MCI study and in a previous AD treatment study with a similar design. The results from this MCI study did not support the hypothesis that rofecoxib would delay a diagnosis of AD. In conjunction with the lack of effects observed in previous AD studies, the findings suggest that inhibition of COX-2 is not a useful therapeutic approach in AD.

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Research works printed but not linked: 3

  1. Bresalier RS, Sandler R, Riddell R, Lanas A, Morton D, Reicin A et al (2004). Preliminary Cardiovascular Safety Data from the APPROVe Study, Presented at the annual meeting of the American College of Rheumatology, San Antonio, Texas, October 18. Abstract available at: http://www.rheumatology.org/annual/press/APPROVesession_annouce.asp .
  2. Sainati S, Ingram D, Talwalker S, Geiss G (2000). Results of a double-blind, randomized, placebo-controlled study of celecoxib in the treatment of the progression of Alzheimer's disease. Sixth International Stockholm/Springfield Symposium on Advances in Alzheimer Therapy, 180 [Abstract].
  3. Schmidt M (1996). Rey Auditory Verbal Learning Test. A Handbook. Western Psychological Services: Los Angeles.

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Metadata

Authors
on behalf of the Rofecoxib Protocol 078 study group, Thal, L. J., Ferris, S. H., Kirby, L., Block, G. A., Lines, C. R., Yuen, E., Assaid, C., Nessly, M. L., Norman, B. A., Baranak, C. C., & Reines, S. A.
Affiliations
  • University of California San Diego (US)
  • New York University (US)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Corresponding author
Lines, Christopher R
ORCID
Ferris, Steven H
Venue
Neuropsychopharmacology
Publisher
Springer Science and Business Media LLC
Published
2005-03-02
Volume
30
Issue
6
Pages
1204-1215
ISSN
  • 0893-133X (ISSN-L)
  • 1740-634X
DOI
10.1038/sj.npp.1300690
OpenAlex
W2051776695
Cited by
402
References
51
Citations by year
2026: 5 · 2025: 9 · 2024: 6 · 2023: 15 · 2022: 16 · 2021: 16 · 2020: 6 · 2019: 12 · 2018: 14 · 2017: 19 · 2016: 15 · 2015: 20 · 2014: 13 · 2013: 14 · 2012: 24
FWCI
21.05
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Neuropsychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • University of Rochester
  • Dartmouth College
  • Towson University
  • York University
  • University of Illinois at Urbana-Champaign
  • School of Medicine, New York University
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Pharmacology (medical) › Inflammatory mediators and NSAID effects
Keywords
rofecoxib, mild cognitive impairment, Alzheimer's disease, COX-2 inhibitors, COX-2 inhibition, disease progression, anti-inflammatory therapy
MeSH terms
Aged, Cognition Disorders, Dementia, Double-Blind Method, Female, Humans, Lactones, Male, Membrane Proteins, Neuropsychological Tests, Prostaglandin-Endoperoxide Synthases, Psychiatric Status Rating Scales, Sulfones, Cyclooxygenase Inhibitors, Disease Progression, Cyclooxygenase 2, Cyclooxygenase 2 Inhibitors

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