Table 2.
Efficacy measure | Intention to treat analysis
|
Observed cases analysis
|
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Placebo | Galantamine 24 mg | Galantamine 32 mg | Treatment difference (95% CI)*
|
Placebo | Galantamine 24 mg | Galantamine 32 mg | Treatment difference (95% CI)*
|
||||
Galantamine 24 mg | Galantamine 32 mg | Galantamine 24 mg | Galantamine 32 mg | ||||||||
11 item cognitive subscale of Alzheimer's disease assessment scale† | |||||||||||
No of patients | 215 | 220 | 217 | 171 | 156 | 152 | |||||
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 | 2.4 (0.44) | −0.7 (0.48) | −1.7 (0.47) | 3.1 (1.7 to 4.5) P<0.001 | 4.1 (2.7 to 5.6) 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 | 68 (40) | 102 (65) | 97 (64) | 25.5 (15.0 to 36.0) P<0.001 | 24.0 (13.0 to 35.0) 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 | 26 (15) | 48 (31) | 53 (35) | 16.0 (7.0 to 25.0) P<0.001 | 19.5 (10.0 to 29.0) P<0.001 | |
Disability assessment for dementia score‡ | |||||||||||
No of patients | 210 | 212 | 214 | 177 | 159 | 157 | |||||
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 | −5.2 (1.21) | −2.7 (1.17) | −1.4 (1.32) | 2.5 (−1.4 to 6.3) P=0.3 | 3.8 (−0.1 to 7.7) P=0.054 | |
Clinician's interview based impression of change plus caregiver input | |||||||||||
No (%) of patients | 203 | 206 | 198 | <0.05§ | <0.001§ | 174 | 161 | 155 | <0.01§ | <0.001§ | |
1=Much improved | 0 | 0 | 0 | 0 | 0 | 0 | |||||
2=Moderately improved | 1 (0.5) | 7 (3) | 9 (5) | 1 (1) | 6 (4) | 8 (5) | |||||
3=Minimally improved | 32 (16) | 29 (14) | 39 (20) | 29 (17) | 27 (17) | 35 (23) | |||||
4=No change | 68 (33) | 91 (44) | 82 (41) | 56 (32) | 75 (47) | 63 (41) | |||||
5=Minimally worsened | 68 (33) | 57 (28) | 54 (27) | 58 (33) | 43 (27) | 41 (26) | |||||
6=Moderately worsened | 32 (16) | 17 (8) | 14 (7) | 28 (16) | 7 (4) | 8 (5) | |||||
7=Much worsened | 2 (1) | 5 (2) | 1 (1) | 2 (1) | 3 (2) | 0 |
Difference from placebo.
Negative change from baseline indicates improvement.
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.