title: Evaluating Response to High-Dose 13.3 mg/24 h Rivastigmine Patch in Patients with Severe Alzheimer's Disease.
abstract: OBJECTIVE
  To identify factors predicting improvement/stabilization on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) and investigate whether early treatment responses can predict long-term outcomes, during a trial of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch in patients with severe Alzheimer's disease (AD).
  
  
  METHODS
  Logistic regression was used to relate Week 24 ADCS-CGIC score to potential baseline predictors. Additional analyses based on receiver-operating characteristic curves were performed using Week 8/16 ADCS-CGIC scores to predict response (13.3 mg/24 h patch) at Week 24. ADCS-CGIC score of (1) 1-3 = "improvement," (2) 1-4 = "improvement or no change".
  
  
  RESULTS
  "Treatment" (13.3 mg/24 h patch) and increased age were significant predictors of "improvement" (P = 0.01 and P = 0.003, respectively), and "treatment" (P = 0.001), increased age (P = 0.002), and prior AD treatment (P = 0.03) for "improvement or no change". At Week 8 and 16, ADCS-CGIC scores of 4 and 5 were optimal thresholds in predicting "improvement," and "improvement or no change," respectively, at Week 24.
  
  
  CONCLUSIONS
  A significant therapeutic effect of high-dose rivastigmine patch on ADCS-CGIC response was observed. The 13.3 mg/24 h patch was identified as a predictor of "improvement" or "improvement or no change". Patients with minimal worsening/improvement/no change after treatment initiation may be more likely to respond following long-term therapy.
authors: Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors: Martin R
authors: MR
authors: Farlow
authors: Division of Neurology, Nova Southeastern University, Fort Lauderdale, FL, USA.|Premiere Research Institute, Palm Beach Neurology, West Palm Beach, FL, USA.
authors: Carl H
authors: CH
authors: Sadowsky
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Drew M
authors: DM
authors: Velting
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Xiangyi
authors: X
authors: Meng
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: M Zahur
authors: MZ
authors: Islam
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D011237:Predictive Value of Tests; D012372:ROC Curve; D000068836:Rivastigmine / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D000068836:Rivastigmine
keywords: Alzheimer disease; Predictor; Receiver-operating characteristic; Rivastigmine; Transdermal patch