Hilkka Soininen1, Christine West, Jeffery Robbins, Liviu Niculescu. 1. Department of Neurology, Kuopio University Hospital and Department of Neurology, Brain Research Unit, Clinical Research Center, Mediteknia, University of Kuopio, Kuopio, Finland. hilkka.soininen@uku.fi
Abstract
BACKGROUND/AIMS: Cyclooxygenase-2 (COX-2) may play an important role in the neuropathology of Alzheimer's disease (AD). The efficacy and safety of celecoxib (200 mg bid), a COX-2 selective inhibitor, were assessed in patients > or =50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function. METHODS: This was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The primary efficacy end points were the change from baseline to week 52 in the Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-cog) composite score and the week 52 Clinician's Interview-Based Impression of Change Plus (CIBIC+). RESULTS: At 52 weeks, change in ADAS-cog scores from baseline was similar for placebo and celecoxib 200 mg bid groups (5.00 and 4.39, respectively). CIBIC+ scores were also similar (4.83 and 4.92). Two extension studies were conducted but were terminated early based on these efficacy results. Safety data from all 3 studies indicated that celecoxib was generally well-tolerated. CONCLUSION:Celecoxib 200 mg bid did not slow the progression of AD in this study, and the occurrence of adverse events was as expected for an elderly population with a complex chronic medical condition. Copyright 2007 S. Karger AG, Basel
RCT Entities:
BACKGROUND/AIMS: Cyclooxygenase-2 (COX-2) may play an important role in the neuropathology of Alzheimer's disease (AD). The efficacy and safety of celecoxib (200 mg bid), a COX-2 selective inhibitor, were assessed in patients > or =50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function. METHODS: This was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The primary efficacy end points were the change from baseline to week 52 in the Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-cog) composite score and the week 52 Clinician's Interview-Based Impression of Change Plus (CIBIC+). RESULTS: At 52 weeks, change in ADAS-cog scores from baseline was similar for placebo and celecoxib 200 mg bid groups (5.00 and 4.39, respectively). CIBIC+ scores were also similar (4.83 and 4.92). Two extension studies were conducted but were terminated early based on these efficacy results. Safety data from all 3 studies indicated that celecoxib was generally well-tolerated. CONCLUSION:Celecoxib 200 mg bid did not slow the progression of AD in this study, and the occurrence of adverse events was as expected for an elderly population with a complex chronic medical condition. Copyright 2007 S. Karger AG, Basel
Authors: Yan Ji; Xiaowan Wang; Colin Kalicki; Blaise W Menta; Megan Baumgardner; Scott J Koppel; Ian W Weidling; Judit Perez-Ortiz; Heather M Wilkins; Russell H Swerdlow Journal: J Alzheimers Dis Date: 2019 Impact factor: 4.472
Authors: Michael R Nichols; Marie-Kim St-Pierre; Ann-Christin Wendeln; Nyasha J Makoni; Lisa K Gouwens; Evan C Garrad; Mona Sohrabi; Jonas J Neher; Marie-Eve Tremblay; Colin K Combs Journal: J Neurochem Date: 2019-03-27 Impact factor: 5.372