Table 1 Patient demographics and baseline characteristics (modified intention-to-treat population)
From: Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials
ApoE ε4 carrier study | ApoE ε4 noncarrier study | ||||
|---|---|---|---|---|---|
Placebo (n = 431) | BAP 0.5 (n = 650) | Placebo (n = 328) | BAP 0.5 (n = 255) | BAP 1.0 (n = 253) | |
Mean age, years | 70.2 | 70.9 | 69.7 | 71.1 | 70.7 |
Female, % | 60.1 | 64.5 | 57.9 | 55.7 | 57.3 |
White, % | 82.6 | 79.5 | 80.5 | 79.2 | 79.4 |
Asian, % | 16.0 | 17.7 | 17.1 | 17.3 | 17.4 |
Black, % | 0.7 | 0.8 | 0.6 | 0.8 | 2.0 |
Other, % | 0.7 | 2.0 | 1.8 | 2.7 | 1.2 |
Mean duration of AD, years (SD) | 2.9 (2.2) | 3.0 (2.2) | 2.8 (2.5) | 2.6 (2.3) | 2.9 (2.2) |
ApoE ε4 allele status, n (%) | |||||
Heterozygous | 334 (77.5) | 500 (76.9) | – | – | – |
Homozygous | 97 (22.5) | 150 (23.1) | – | – | – |
Using anti-AD medication at baseline, n (%) | 386 (89.6) | 578 (88.9) | 274 (83.5) | 204 (80.0) | 209 (82.6) |
Mean MMSE score (SD) | 21.0 (3.0) | 20.9 (3.1) | 20.8 (3.1) | 20.8 (3.2) | 20.8 (3.1) |
Mean years of formal education (SD) | 12.5 (3.6) | 12.2 (3.7) | 11.8 (3.9) | 11.9 (3.9) | 11.8 (3.9) |
Substudy participation, n (%) | |||||
vMRI + PET or vMRI + PET + CSF | 47 (10.9) | 64 (9.8) | 34 (10.4) | 27 (10.6) | 21 (8.3) |
CSF or CSF + vMRI | 104 (24.1) | 160 (24.6) | 67 (20.4) | 44 (17.3) | 53 (20.9) |
vMRI only | 161 (37.4) | 241 (37.1) | 112 (34.1) | 92 (36.1) | 88 (34.8) |
No substudy | 119 (27.6) | 185 (28.5) | 115 (35.1) | 92 (36.1) | 91 (36.0) |
Mean ADAS-Cog/11 score (SD) | 22.6 (8.9) | 23.2 (8.9) | 22.9 (10.2) | 23.2 (10.0) | 23.5 (9.3) |
Mean DAD score (SD) | 80.9 (18.7) | 79.9 (18.3) | 79.6 (17.9) | 78.6 (20.0) | 79.0 (18.4) |
Infusions received, n (%) | |||||
1 | 13 (3.0) | 34 (5.2) | 40 (12.2) | 22 (8.6) | 29 (11.5) |
2 | 17 (3.9) | 42 (6.5) | 44 (13.4) | 37 (14.5) | 46 (18.2) |
3 | 29 (6.7) | 57 (8.8) | 36 (11.0) | 31 (12.2) | 25 (9.9) |
4 | 28 (6.5) | 46 (7.1) | 33 (10.1) | 24 (9.4) | 26 (10.3) |
5 | 43 (10.0) | 98 (15.1) | 40 (12.2) | 35 (13.7) | 30 (11.9) |
6 | 301 (69.8) | 373 (57.4) | 134 (40.9)a | 106 (41.6) | 97 (38.3) |