Page 204 - Drug Class Review
P. 204

Page 132 of 205
             Drug Effectiveness Review Project































                                        placebo   75.1   60   NR      2.5      24.3     Primary Outcome Measures: Change from baseline to end point on the modified ADAS-cog total score  Secondary Outcome Measures: Change from baseline on the MMSE; CDR-Sum of Boxes; CMBT;   Significant improvement over placebo was observed in the donepezil group at endpoint on the modified  Significant improvement over placebo was observed in the donepezil group (+1.8 points) at  Significant improvement over placebo was observed in the donepezil group at endpoint on the  following CMBT tasks:  name-face association delayed recall (P = 0.04),














                                 Groups similar at baseline: Yes
                                    Alzheimer classification: Mild





                                        donepezil   73.3   50   NR      2.9      24.1       Timing of assessments: Screening, baseline, every 6 weeks   Health Outcome Measures:  ADAS-cog total score (difference 2.3 points);  P = 0.001  Intermediate Outcome Measures:   endpoint on MMSE scores (P = 0.002)   other CMBT scales




                                                                                  Apathy Scale                  •     •             •






















             Final Report Update 1     Authors: Seltzer et al.   Year: 2004   POPULATION  CHARACTERISTICS:       Mean age (years):   Sex (% female):   Ethnicity:   Other germane population qualities:  Onset cognitive symptoms   •   (yrs)   MMSE   •     OUTCOME ASSESSMENT:          RESULTS:     Alzheimer's Drugs
   199   200   201   202   203   204   205   206   207   208   209