Table 2.
Change from baseline in the primary efficacy endpoint of BOLD fMRI slope at Days 2 and 90, ROI1
| Treatment group | n | Geo‐metric mean | SEa | 90% CIb | Geo‐metricmean ratio | SEa | 90% CIb | Mean/SEa | Probability (Treatment Effect>x), where x= | C1c achieved | C2d achieved | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0% | 20% | |||||||||||
| Day 2 | ||||||||||||
| Ponezumab | 20 | 0.954 | 0.085 | (0.831, 1.096) | 0.984 | 0.112 | (0.820, 1.184) | −0.146 | 0.4367 | 0.0390 | No | No |
| Placebo | 11 | 0.969 | 0.073 | (0.861, 1.092) | ||||||||
| Day 90 | ||||||||||||
| Ponezumab | 20 | 0.817 | 0.064 | (0.736, 0.908) | 0.852 | 0.091 | (0.735, 0.989) | –1.761 | 0.0390 | 0.0002 | No | No |
| Placebo | 10 | 0.958 | 0.063 | (0.864, 1.064) | ||||||||
The units for slope are percent/second.
Abbreviations: BOLD, blood oxygenation level dependent; CI, credible interval; fMRI, functional magnetic resonance imaging; n, number of subjects; ROI, region of interest; SE, standard error.
a
Log scale value presented.
b
A credible interval was defined as a posterior probability interval.
c
Point estimate of ponezumab versus placebo effect >20% increase (improvement) in slope.
d
Standard error of ponezumab versus placebo effect <60% of the point estimate.