Table 5.
Tabulation of post-hoc statistical analysis results comparing changes from baseline of plasma brain derived (BD) Tau in active treatment study arms (ACI-35.030 or JACI-35.054) versus corresponding changes in the pooled placebo study arm.
| Week | Group | Change from baseline LSa mean (95% CIb) |
Change from baseline LS mean expressed as % relative to baseline |
Difference from placebo (95% CI) | p-valuec |
|---|---|---|---|---|---|
| 42 | Pooled placebo | 0.22 (−0.83 to 1.27) | 4.0% | ||
| ACI-35.030 900 μg | 1.57 (0.62–2.51) | 28.5% | 1.35 (−0.07 to 2.76) | 0.0625 | |
| ACI-35.030 1800 μg | 2.21 (0.77–3.66) | 37.3% | 1.99 (0.20–3.78) | 0.0291 | |
| 50 | Pooled placebo | 0.16 (−0.78 to 1.10) | 2.9% | ||
| ACI-35.030 900 μg | 1.59 (0.77–2.41) | 28.8% | 1.43 (0.18–2.68) | 0.0250 | |
| ACI-35.030 1800 μg | 1.86 (0.33–3.40) | 31.4% | 1.71 (−0.09 to 3.50) | 0.0625 | |
| 67 | Pooled placebo | −0.00 (−0.94 to 0.94) | 0% | ||
| ACI-35.030 900 μg | 1.36 (0.53–2.20) | 24.7% | 1.37 (0.11–2.62) | 0.0332 | |
| ACI-35.030 1800 μg | 2.16 (0.63–3.70) | 36.5% | 2.17 (0.37–3.96) | 0.0183 | |
| 74 | Pooled placebo | 0.45 (−0.48 to 1.39) | 8.3% | ||
| ACI-35.030 900 μg | 1.98 (1.15–2.82) | 35.9% | 1.53 (0.27–2.79) | 0.0175 | |
| ACI-35.030 1800 μg | 2.31 (0.78–3.84) | 30.0% | 1.86 (0.06–3.65) | 0.0430 | |
| 20 | Pooled placebo | −0.06 (−1.39 to 1.26) | −1.1% | ||
| JACI-35.054 15 μg | Non estimated | Non estimated | Non estimated | – | |
| JACI-35.054 60 μg | 2.43 (0.78–4.07) | 39.8% | 2.49 (0.37–4.61) | 0.0219 |
a
Least Squares.
b
Confidence Interval.
c
Linear Mixed Model with baseline and treatment arm∗visit as fixed factors, participant ID as random factor, Satterthwaite's method for degrees of freedom, uncorrected p-values.