Table 2 Summary of change from baseline to week 12 in primary, secondary and further endpoints from the pooled analysis (mixed-model repeated measurement)
Endpoints | BI 409306 10 mg QD (n = 67) | BI 409306 25 mg QD (n = 63) | BI 409306 50 mg QD (n = 67) | BI 409306 25 mg BID (n = 63) | Placebo (n = 122) |
|---|---|---|---|---|---|
Primary endpoint | |||||
NTB total z-score | |||||
Adjusted mean (SE) change from baseline | 0.20 (0.046) | 0.19 (0.048) | 0.19 (0.046) | 0.10 (0.047) | 0.19 (0.035) |
p value* | 0.87 | 0.95 | 0.93 | 0.13 | – |
Secondary endpoints | |||||
CDR-SB | |||||
Adjusted mean (SE) change from baseline | 0.1 (0.170) | 0.3 (0.170) | 0.1 (0.170) | 0.1 (0.170) | 0.0 (0.120) |
p value* | 0.82 | 0.20 | 0.94 | 0.66 | |
ADAS-Cog11 | |||||
Adjusted mean (SE) change from baseline | 1.13 (0.593) | 0.80 (0.623) | 0.82 (0.596) | 1.32 (0.596) | 0.27 (0.444) |
p value* | 0.25 | 0.49 | 0.46 | 0.16 | – |
Study 1: ADCS-MCI-ADL | |||||
Adjusted mean (SE) change from baseline | 0.24 (0.896) | 1.79 (0.921) | − 0.10 (0.875) | 0.80 (0.947) | 0.38 (0.642) |
p value* | 0.90 | 0.21 | 0.66 | 0.72 | – |
Study 2: ADCS-ADL | |||||
Adjusted mean (SE) change from baseline | 0.10 (0.853) | − 0.99 (0.892) | 0.35 (0.847) | − 1.07 (0.855) | − 0.58 (0.639) |
p value* | 0.53 | 0.71 | 0.38 | 0.65 | – |
Further endpoints | |||||
NTB memory domain subscale | |||||
Adjusted mean (SE) change from baseline | 0.34 (0.053) | 0.27 (0.055) | 0.25 (0.053) | 0.15 (0.054) | 0.26 (0.04) |
p value* | 0.22 | 0.81 | 0.92 | 0.10 | – |
NTB executive-function domain subscale | |||||
Adjusted mean (SE) change from baseline | − 0.04 (0.062) | − 0.02 (0.064) | 0.07 (0.062) | 0.01 (0.063) | 0.05 (0.046) |
p value* | 0.22 | 0.38 | 0.77 | 0.56 | – |
NTB immediate-memory domain subscale | |||||
Adjusted mean (SE) change from baseline | 0.37 (0.066) | 0.32 (0.069) | 0.38 (0.067) | 0.22 (0.068) | 0.38 (0.05) |
p value* | 0.95 | 0.50 | 0.95 | 0.06 | – |