Table 2. Change from baseline in measures of efficacy at six months, intention to treat analysis


Efficacy measure Placebo Galantamine 24 mg Galantamine 32 mg Treatment difference (95% CI)*
Galantamine 24 mg Galantamine 32 mg

11 item cognitive subscale of Alzheimer's disease assessment scaledagger
  No of patients 215 220 217
Mean (SE) change from baseline 2.4 (0.41)  -0.5 (0.38)  -0.8 (0.43) 2.9 (1.6 to 4.1) P<0.001 3.1 (1.9 to 4.4) P<0.001
No (%) with >= 0 points improvement 88 (41) 138 (63) 130 (60) 21.5 (12.0 to 31.0) P<0.001 19.5 (10.0 to 29.0) P<0.001
No (%) with >= 4 points improvement 32 (15) 64 (29) 70 (32) 14.0 (6.0 to 22.0) P<0.001 17.0 (9.0 to 25.0) P<0.001
Disability assessment for dementia scoreDagger
  No of patients 210 212 214
Mean (SE) change from baseline  -6.0 (1.08)  -3.2 (1.02)  -2.5 (1.07) 2.8 (-0.6 to 6.1) P=0.1 3.4 (0.1 to 6.7) P<0.05
Clinician's interview based impression of change plus caregiver input
  No (%) of patients 203 206 198 <0.05§ <0.001§
1=Much improved 0 0 0
2=Moderately improved 1 (0.5) 7 (3) 9 (5)
3=Minimally improved 32 (16) 29 (14) 39 (20)
4=No change 68 (33) 91 (44) 82 (41)
5=Minimally worsened 68 (33) 57 (28) 54 (27)
6=Moderately worsened 32 (16) 17 (8) 14 (7)
7=Much worsened 2 (1) 5 (2) 1 (1)

* Difference from placebo.
dagger Negative change from baseline indicates improvement.
Dagger Negative change from baseline indicates deterioration.
§ Van Elteren test was used to test for differences in the distribution of scores between placebo and galantamine groups. For details of the observed case analysis see table 2 on BMJ's website.




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