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Final Report Update 1                                             Drug Effectiveness Review Project




               Table 4: Summary of trials assessing symptoms and behavioral disturbances

                  Author, Year    Mean    N   Duration  Disease                Results               Quality
                                   Age        (weeks)   Severity                                     Rating
                                 (years)
                                                  Donepezil vs. Galantamine
               Wilcock et al.,     73    188     52       NR      Symptoms: No significant differences in   N/A*
                   27
               2003                                                cognition
                                                                  Behavior / function: No significant
                                                                   differences in behavior, measures of
                                                                   daily functioning, or caregiver burden
               Jones et al., 2004 28  74  120    12      Mild  -  Symptoms: significantly better cognitive   N/A*
                                                       moderate    scores for DON-treated patients
                                                                  Behavior / function: Significantly better
                                                                   physician & caregiver satisfaction and
                                                                   less disability for DON-treated patients
                                                  Donepezil vs. Rivastigmine
               Wilkinson et al.,   74    111     12      Mild  -  Symptoms: No significant differences in   N/A*
                   29
               2002                                    moderate    cognition
                                                                  Behavior / function: Clinician and
                                                                   caregiver satisfaction significantly
                                                                   better with DON
                                      Donepezil, Galantamine, and Rivastigmine vs. Placebo
               Lanctot et al., 2003   NR  7954   ≥ 12     NR      Symptoms: Pooled NNT to yield one   Good
                   30
               (MA)                             weeks              additional ChEI global responder was
                                                                   12; NNT to yield one additional
                                                                   cognitive responder was 10
                                                                  Behavior / function: NR
               Kaduszkiewicz et al.,   NR  9030  ≥ 6      NR      Symptoms: small beneficial effects for   Fair
                        31
               2005 (MA)                        weeks              ChEI compared to placebo; the mean
                                                                   difference was 1.5 to 3.9 points for the
                                                                   ADAS-cog and 0.26 to 0.54 points for
                                                                   the CIBIC-plus
                                                                  Behavior / function: NR
                                                    Donepezil vs. Placebo
               Birks, 2004 (MA) 32  NR   436    > 12     Mild –   Symptoms: significantly better cognitive   Good
                                          5            moderate    and global assessment scores for DON
                                                                  Behavior / function: no differences in
                                                                   QoL and functional capacity
               Whitehead et al.,   NR    237   12-24     Mild  -  Symptoms: significantly better ADAS-  Fair
                        33
               2004 (MA)                  6            moderate    cog scores for DON treated patients
                                                                  Behavior / function: no difference in QoL
               AD2000** 38         76    565    192      Mild  -  Symptoms: significantly better cognition   Fair
                                                       moderate    scores for DON
                                                                  Behavior / function: no differences in
                                                                   rates of institutionalization and
                                                                   progression of functional decline
               Burns et al., 1999 39  72  818    24      Mild  -  Symptoms: significantly better cognitive   Fair
                                                       moderate    and global assessment scores for DON
                                                                  Behavior / function: no difference in QoL
               Feldman et al.,     74    290     24    Moderate   Symptoms: significantly better cognitive   Good
               2001 40, 71-73                           - severe   and global assessment scores for DON
                                                                  Behavior / function: slower decline of
                                                                   measures of daily functioning for DON
               Homma et al.,       70    268     24      Mild  -  Symptoms:  significantly better cognitive   Fair
                   41
               2000                                    moderate    and global assessment scores for DON
                                                                  Behavior / function: slower decline of
                                                                   function in DON patients




                 Alzheimer's Drugs                                                               Page 29 of 205
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