Page 133 - Drug Class Review
P. 133

Communicative Disorders and Stroke—Alzheimer Disease and Related Disorders Association with
                                               one exception where a DSM-IV diagnosis of dementia was used for inclusion; Fourteen of 22 trials
             Drug Effectiveness Review Project
                                 Duration of treatment varied between six weeks and three years;  Number of patients included per
                                        probable or possible Alzheimer’s disease, according to the National Institute of Neurological and
                                    study varied between 27 and 978;  All studies included patients with an established diagnosis of









                                                      to assess efficacy  used the ADAS-cog as the primary measurement of efficacy; In 12 trials, the CIBIC-plus was used  Methodological assessment of all studies found considerable flaws:  The use of several  “primary end points without correction for multiple comparisons. After correction, two of  the five trials on rivastigmine do not show any significant benefit on primary endpoint  measures any more; missing ITT analysis, as in 15 of the 22 trials patients were excluded  from analysis after randomization; In at least eight of the trials the last observation carried  forwa












                                                          •                               Yes       Yes          Good











             Final Report Update 1    Authors: Kaduszkiewicz et al.    Year: 2005   CHARACTERISTICS OF   INTERVENTIONS:         MAIN RESULTS:      ADVERSE EVENTS:      COMPREHENSIVE  LITERATURE SEARCH   STRATEGY:  STANDARD METHOD OF  APPRAISAL OF STUDIES:         QUALITY RATING:               Alzheimer's Drugs
   128   129   130   131   132   133   134   135   136   137   138