Page 180 - Drug Class Review
P. 180

Page 120 of 205
             Drug Effectiveness Review Project





                                                                  placebo   N/A   12 weeks   153
                                                 To examine the efficacy and safety of DON in treatment of mild to moderately severe AD



















                                                                  donepezil 10 mg   10 mg/d   12 weeks   158  >50 yrs old; diagnosis of probable AD consistent with NINCDS and DSM-IV criteria; mild to moderately  severe disease based on MMSE scores of 10-26; CDR scores of 1 or 2   Major medical illness – diabetes, COPD, asthma, hematologic or oncologic disorders; vitamin B 12 or  folate deficiency; gastrointestinal, renal, hepatic, endocrine, or cardiovascular disease; evidence of other  psychiatric or neurological disorders; HIS score > 5; known hypersensitivity to ChE inhibitors  Occasional use of hypnotics and cold prepara




























                          Drugs   Authors:  Rogers et al. 43    Eisai Inc, Teaneck NJ and Eisai Co Ltd, Tokyo Japan   Setting: Multi-center (23 clinical centers)   donepezil 5 mg   5 mg/d   12 weeks   157   certain antihypertensives were prohibited




                          Alzheimer     Year:  1998   Country: US      Study design: RCT   Sample size: 468





















             Final Report Update 1     Efficacy/Effectiveness  STUDY:      FUNDING:   RESEARCH OBJECTIVE:      DESIGN:           INTERVENTION:    Dose:     Duration:     Sample size:   INCLUSION:   EXCLUSION:   OTHER MEDICATIONS/  INTERVENTIONS ALLOWED:     Alzheimer's Drugs
   175   176   177   178   179   180   181   182   183   184   185