|
Memantine
|
No memantine
|
Placebo
|
---|
Placebo
|
Galantamine
|
Placebo
|
Galantamine
|
Memantine vs no memantine
|
---|
Time to death
|
n/J (%)
|
15/245 (6.1)
|
19/251 (7.6)
|
41/776 (5.3)
|
14/773 (1.8)
| |
Death rate (per 100 patient-years)
|
4.49
|
5.57
|
4.15
|
1.39
| |
Hazard ratio (95 % CI)
|
1.25 (0.63; 2.46)
|
0.33 (0.18; 0.61)
|
1.16 (0.65; 2.06)
|
MMSE over time (change from baseline)
|
6 months
|
n
|
215
|
202
|
673
|
671
| |
Mean (SD)
|
–0.49 (3.41)
|
–0.25 (3.01)
|
–0.22 (2.77)
|
0.27 (2.63)
| |
Effect size (95 % CI)
|
0.07 (–0.12; 0.27)
|
0.18 (0.07; 0.29)
|
p = 0.2410
|
12 months
|
n
|
215
|
202
|
676
|
672
| |
Mean (SD)
|
–1.09 (3.84)
|
–1.09 (3.54)
|
–1.09 (3.45)
|
–0.34 (3.16)
| |
Effect size (95 % CI)
|
0.0 (–0.19; 0.19)
|
0.23 (0.12; 0.33)
|
p = 1.00
|
18 months
|
n
|
215
|
202
|
676
|
672
| |
Mean (SD)
|
–1.8 (3.89)
|
–1.86 (4.24)
|
–1.73 (4.03)
|
–0.84 (3.64)
| |
Effect size (95 % CI)
|
–0.01 (–0.21; 0.18)
| |
0.23 (0.12; 0.34)
| |
p = 0.8231
|
24 months
|
n
|
215
|
202
|
676
|
672
| |
Mean (SD)
|
–2.10 (4.14)
|
–2.35 (4.48)
|
–2.15 (4.41)
|
–1.12 (3.87)
| |
Effect size (95 % CI)
|
–0.06 (–0.25; 0.13)
| |
0.25 (0.14; 0.36)
| |
p = 0.8832
|
DAD over time (change from baseline)
|
12 months
|
n
|
201
|
182
|
620
|
628
| |
Mean (SD)
|
–7.70 (18.34)
|
–6.58 (18.59)
|
–6.10 (15.38)
|
–3.94 (13.29)
| |
Effect size (95 % CI)
|
0.06 (–0.14; 0.26)
| |
0.15 (0.04; 0.26)
| |
p = 0.2227
|
24 months
|
n
|
202
|
182
|
620
|
628
| |
Mean (SD)
|
–13.33 (20.79)
|
–11.78 (20.76)
|
–9.99 (17.31)
|
–7.11 (15.96)
| |
Effect size (95 % CI)
|
0.07 (–0.13; 0.28)
| |
0.17 (0.06; 0.28)
| |
p = 0.0237
|
New nursing home placement (change from baseline (for 12 months) or from 12 months (for 24 months))
|
12 months
|
n
|
100
|
81
|
252
|
249
| |
Number (%)
|
3 (3)
|
9 (11.1)
|
4 (1.6)
|
3 (1.2)
| |
Relative risk (95 % CI)
|
3.70 (1.04; 13.23)
|
0.76 (0.17; 3.36)
| |
χ2, p value
|
4.76, p = 0.0292
| |
0.13, p = 0.7153
| | |
24 months
|
n
|
48
|
52
|
149
|
161
| |
Number (%)
|
1 (2)
|
4 (7.7)
|
5 (3.4)
|
1 (0.6)
| |
Relative risk (95 % CI)
|
3.70 (0.43; 31.89)
|
0.19 (0.02; 1.57)
| |
χ2, p value
|
1.65, p = 0.1985
|
3.05, p = 0.0808
| |
New nursing home placement at 24 months (%)
|
5
|
18.8
|
5
|
1.8
| |
-
DAD Disability Assessment for Dementia, MMSE Mini-Mental State Examination, SD standard deviation
-
n = the number of death cases; J = the number of subjects in each subgroup