Table 1 Patient demographics and baseline characteristics (pooled analysis)
BI 409306 10 mg QD (n = 77) | BI 409306 25 mg QD (n = 74) | BI 409306 50 mg QD (n = 76) | BI 409306 25 mg BID (n = 76) | Placebo (n = 149) | |
|---|---|---|---|---|---|
Male, n (%) | 41 (53.2) | 32 (43.2) | 42 (55.3) | 33 (43.4) | 73 (49.0) |
Age (years), mean (SD) | 73.3 (7.7) | 74.2 (7.8) | 73.1 (6.1) | 74.0 (8.4) | 73.5 (7.4) |
Race, n (%) | |||||
Asian | 1 (1.3) | 0 (0) | 1 (1.3) | 0 (0) | 0 (0) |
Black or African American | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2.0) |
White | 76 (98.7) | 74 (100.0) | 75 (98.7) | 76 (100.0) | 146 (98.0) |
Body mass index, (kg/m2), mean (SD) | 26.0 (3.4) | 27.2 (5.2) | 26.7 (3.7) | 25.5 (3.9) | 26.2 (4.1) |
Smoking status, n (%) | |||||
Never smoked | 38 (49.4) | 47 (63.5) | 43 (56.6) | 44 (57.9) | 79 (53.0) |
Ex-smoker | 30 (39.0) | 24 (32.4) | 30 (39.5) | 25 (32.9) | 61 (40.9) |
Current smoker | 9 (11.7) | 3 (4.1) | 3 (3.9) | 7 (9.2) | 9 (6.0) |
Alcohol status, n (%) | |||||
Non-drinker | 36 (46.8) | 30 (40.5) | 29 (38.2) | 37 (48.7) | 72 (48.3) |
Drinks—no interference | 41 (53.2) | 44 (59.5) | 47 (61.8) | 39 (51.3) | 77 (51.7) |
Drinks—possible interference | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
ApoE e4-positive, n (%) | |||||
e3/e4 | 29 (37.7) | 25 (33.8) | 32 (42.1) | 22 (28.9) | 62 (41.6) |
e4/e4 | 5 (6.5) | 8 (10.8) | 7 (9.2) | 11 (14.5) | 15 (10.1) |
NTB total | |||||
n | 71 | 67 | 73 | 67 | 134 |
Mean (SD) | 0.05 (0.66) | − 0.12 (0.61) | 0.01 (0.67) | 0.05 (0.65) | − 0.03 (0.66) |
Median (range) | 0.01 (−1.7–1.8) | − 0.09 (− 1.6–1.6) | − 0.03 (− 1.2–1.7) | 0.12 (− 1.5–1.9) | 0.05 (− 1.7–2.1) |
ADAS-Cog11 total | |||||
n | 70 | 66 | 69 | 69 | 129 |
Mean (SD) | 16.90 (7.79) | 19.23 (7.70) | 17.45 (8.05) | 19.43 (8.7) | 18.52 (8.31) |
Median (range) | 16.33 (2.3–41.0) | 19.00 (4.0–38.0) | 15.67 (3.0–39.7) | 17.33 (6.0–49.7) | 17.00 (2.7–41.7) |
CDR-SB total | |||||
n | 75 | 73 | 76 | 74 | 148 |
Mean (SD) | 4.75 (2.13) | 4.76 (2.23) | 4.70 (2.17) | 5.18 (2.78) | 4.91 (2.43) |
Median (range) | 4.50 (0.5–12.0) | 4.50 (1.0–10.0) | 4.50 (0.5–10.0) | 5.00 (0.5–14.0) | 4.50 (0.5–14.0) |