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. 2000 Dec 9;321(7274):1445. doi: 10.1136/bmj.321.7274.1445

Table 2.

Change from baseline in measures of efficacy at six months

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.