Table 5.
Mean changes from baseline at week 24 in the 4-week dosing interval (Intent-to-treat population; n=55).
| IVIG (n=21) | Placebo (n=7) | Placebo vs. 0.2 IVIG | Placebo vs. 0.5 IVIG | Placebo vs. 0.8 IVIG | ||||
|---|---|---|---|---|---|---|---|---|
| 0.2 (n=6) | 0.5 (n=8) | 0.8 (n=7) | ||||||
| Aβ1–40: | 561.7 ± 1195.5 (n=6) |
403.9 ± 588.1 (n=8) |
642.2 ± 1171.3 (n=6) |
42.0 ± 874.0 (n=6) |
−519.7 [−1866.7; 827.4] p=0.4102 |
−361.9 [−1210.4; 486.6] p=0.3711 | −600.2[−1929.5; 729.2] p=0.3382 |
|
| CSF* [pg/mL] | ||||||||
| Plasma [pg/mL] | −20.3 ± 29.2 (n=6) |
15.7 ± 29.7 (n=7) |
−30.5 ± 42.3 (n=6) |
−6.0 ± 23.8 (n=6) |
14.3 [−19.9; 48.6] p=0.3729 |
−21.7 [−55.0; 11.6] p=0.1788 |
24.5 [−19.7; 68.7] p=0.2446 |
|
| Aβ1–42: | 18.8 ± 40.3 (n=6) |
10.5 ± 40.9 (n=8) |
24.7 ± 43.2 (n=6) |
−5.2 ± 36.3 (n=6) |
−24.0 [−73.3; 25.3] p=0.3037 |
−15.7 [−61.6; 30.3] p=0.4718 |
−29.8 [−81.1; 21.4] p=0.2239 |
|
| CSF* [pg/mL] | ||||||||
| Plasma [pg/mL] | −3.5 ± 5.8 (n=6) |
−0.1 ± 4.4 (n=8) |
−7.0 ± 6.2 (n=6) |
−2.0 ± 4.8 (n=6) |
1.5 [−5.3; 8.3] p=0.6349 |
−1.9 [−7.2; 3.5] p=0.4606 |
5.0 [−2.2; 12.2] p=0.1509 |
|
| nAbs-Aβ: | 0.4 ± 1.4 (n=6) |
1.1 ± 1.5 (n=8) |
0.7 ± 2.3 (n=6) |
0.1 ± 0.3 (n=6) |
−0.3 [−1.6; 1.1] p=0.6881 |
−1.0 [−2.3; 0.4] p=0.1083 |
−0.6 [−2.7; 1.5] p=0.5596 |
|
| CSF* [RTF] | ||||||||
| Plasma [RTF] | 96.7 ± 133.7 (n=6) |
256.6 ± 214.1 (n=8) |
501.3 ± 514.6 (n=6) |
−56.3 ± 58.3 (n=6) |
153.0 [−285.6; −20.4] p=0.0279 |
−313.0 [−510.4; −115.6] p=0.0039 |
−557.7 [−1028.8; −86.6] p=0.0450 |
|
| Total tau* [pg/mL] | −141.8 ± 419.5 (n=6) |
1.3 ± 86.7 (n=8) |
131.3 ± 301.0 (n=6) |
−33.2 ± 69.7 (n=6) |
108.7 [−278.2; 495.5] p=0.5575 |
−34.4 [−128.6; 59.8] p=0.4416 |
−164.5 [−445.6; 116.6] p=0.2438 |
|
| P-Tau181* [pg/mL] | 3.3 ± 21.2 (n=6) |
−2.5 ± 8.6 (n=8) |
10.2 ± 19.3 (n=6) |
−1.3 ± 10.1 (n=6) |
−4.7 [−26.0; 16.7] p=0.6370 |
1.2 [−9.7; 12.0] p=0.8192 |
−11.5 [−31.3; 8.3] p=0.2243 |
|
| ADAS-cog | 5.33 [−4.7; 8.7] (n=6) |
1.84 [−8.0; 24.0] (n=8) |
−1.50 [−4.3; 18.3] (n=6) |
0.33 [−3.3; 5.0] (n=5) |
−3.84 [−9.34; 4.00] p=0.2353 |
−0.34 [7.00; 5.67] p=0.8835 |
0.84 [−13.33; 7.33] p=0.6466 |
|
| MMSE | −3.0 [−8; 2] (n=6) |
−1.5 [−4; 1] (n=8) |
−1.5 [−7; 2] (n=6) |
−1.5 [−11; 4] (n=6) |
2.0 [−6.0; 7.0] p=0.5725 |
0.5 [−5.0; 5.0] p=0.8453 |
0.0 [−6.0; 5.0] p=1.0000 |
|
| CDR-SOB | 0.50 [−1.0; 3.0] (n=6) |
0.00 [−1.0; 5.0] (n=8) |
0.25 [−1.5; 3.0] (n=6) |
−0.50 [−6.0; 0.0] (n=5) |
−1.50 [−6.50; 0.00] p=0.0641 |
−0.50 [−6.00; 0.00] p=0.1879 |
−1.25 [−5.50; 0.50] p=0.1961 |
|
| ADCS-ADL | −3.0 [−31; 11] (n=6) | 0.0 [−15; 11] (n=8) |
−1.5 [−5; 3] (n=6) |
−3.0 [−8; 7] (n=5) |
−1.0 [−13.0; −25.0] p=0.9273 |
−4.5 [−14.0; 7.0] p=0.3387 |
−1.5 [−8.0; 6.0] p=0.7144 |
|
|
Whole brain volume |
−1.4 ± 1.8 (n=6) |
−1.1 ± 1.0 (n=8) |
−1.6 ± 1.1 (n=6) |
−0.9 ± 0.8 (n=4) |
0.5 [−1.7; 2.7] p=0.6196 |
0.2 [−1.1; 1.5] p=0.7094 |
0.7 [−0.7; 2.2] p=0.2851 |
|
|
Hippocampal volume left |
−191.2 ± 111.7 (n=6) |
−188.4 ± 228.2 (n=8) |
−153.5 ± 91.2 (n=6) |
−137.0 ± 114.8 (n=5) |
54.2 [−100.8; 209.1] p=0.4494 |
51.4 [−193.0; 295.7] p=0.6526 |
16.5 [−123.7; 156.7] p=0.7961 |
|
|
Hippocampal volume right |
−140.8 ± 60.3 (n=6) |
−193.1 ± 137.7 (n=8) |
−230.5 ± 165.8 (n=6) |
−132.4 ± 122.1 (n=5) |
8.4 [−118.9; 135.8] p=0.8842 |
60.7 [−105.2; 226.6] p=0.4375 |
98.1 [−104.6; 300.8] p=0.3021 |
|
Data are mean ± SD (patients analysed) for CSR and plasma biomarkers as well as MRI results and median [minimum, maximum] (patients analysed) for cognitive and functional scales.
Differences between treatment groups were assessed by using t-test (two-sided, α=0.05) for CSF and plasma biomarkers as well as MRI results (displayed as difference between groups [95% confidence interval], p-value) and by calculating Hodges-Lehmann estimates and the corresponding non-parametric 95% confidence interval as well as by using Wilcoxon Rank Sum test (normal approximation, two-sided, α=0.05) for the cognitive and functional scales (displayed as Hodges-Lehmann estimate [95% confidence interval] p-value).
At visit 7 (last infusion at week 20 + 1 day)