Table 6.

Mean changes from baseline at week 24 in 2-week dosing interval (Intent-to-treat population; n=55).

			IVIG (n=20)		Placebo (n=7)	Placebo vs. 0.1 IVIG	Placebo vs. 0.25 IVIG	Placebo vs. 0.4 IVIG
		0.1 (n=6)	0.25 (n=7)	0.4 (n=7)
Aβ1–40:		266.7 ± 996.0 (n=6)	10.6 ± 1104.0 (n=7)	−147.0 ± 1067.9 (n=5)	939.4 ± 1670.8 (n=5)	672.7 [−1160.8; 2506.3] p=0.4280	928.8 [844.7; 2702.3] p=0.2703	1086.4 [−958.5; 3131.3] p=0.2554
CSF* [pg/mL]
Plasma [pg/mL]		5.5 ± 64.5 (n=6)	−0.3 ± 22.1 (n=6)	−6.5 ± 61.4 (n=6)	27.1 ± 40.2 (n=7)	21.6 [−42.8; 86.1] p=0.4755	27.5 [−13.2; 68.1] p=0.1650	33.6 [−28.7; 96.0] p=0.2602
Aβ1–42:		−8.7 ± 38.2 (n=6)	9.7 ± 54.7 (n=7)	4.0 ± 40.3 (n=5)	32.42 ± 67.0 (n=5)	41.1 [−31.5; 113.7] p=0.2327	22.7 [−55.9; 100.9] p=0.5325	28.4 [−52.2; 109.0] p=0.4403
CSF* [pg/mL]
Plasma [pg/mL]		−2.3 ± 7.8 (n=6)	−4.5 ± 6.3 (n=6)	−2.7 ± 7.6 (n=6)	4.1 ± 3.8 (n=7)	6.5 [−0.8; 13.8] p=0.0759	8.6 [2.4; 14.8] p=0.0107	6.8 [−0.3; 13.9] p=0.0592
nAbs-Aβ:		0.2 ± 1.8 (n=6)	1.9 ± 1.9 (n=7)	−0.8 ± 1.6 (n=5)	0.4 ± 3.7 (n=5)	0.2 [−3.7; 4.0] p=0.9271	−1.5 [−5.1; 2.2] p=0.3861	1.2 [−3.0; 5.4] p=0.5378
CSF* [RTF]
Plasma [RTF]		74.3 ± 35.0 (n=6)	163.9 ± 136.6 (n=7)	310.2 ± 193.0 (n=6)	109.7 ± 284.8 (n=7)	35.4 [−223.8; 294.6] p=0.7553	−54.1 [−314.3; 206.0] p=0.6583	−200.5 [−503.3; 102.4] p=0.1732
Total tau* [pg/mL]		209.3 ± 416.0 (n=6)	−3.4 ± 35.6 (n=7)	−7.8 ± 51.3 (n=5)	17.4 ± 38.6 (n=5)	−191.9 [−618.1; 234.3] p=0.3110	20.8 [−27.2; 68.9] p=0.3571	25.2 [−41.0; 91.4] p=0.4056
P-Tau181* [pg/mL]		−3.2 ± 14.7 (n=6)	0.4 ± 3.6 (n=7)	2.6 ± 5.0 (n=5)	0.6 ± 7.5 (n=5)	3.8 [−12.7; 20.2] p=0.6172	0.2 [−7.0; 7.4] p=0.9586	−2.0 [−11.3; 7.3] p=0.6328
ADAS-cog		2.50 [−3.7; 6.0] (n=6)	−1.33 [−7.3; 4.0] (n=7)	4.50 [−4.0; 8.3] (n=6)	−0.33 [−5.3; 5.0] (n=7)	−3.00 [−7.00; 1.67] p=0.1979	2.00 [−4.00; 7.00] p=0.6540	−4.34 [−10.66; 2.33] p=0.1004
MMSE		−2.0 [−10; 2] (n=6)	0.0 [−3; 4] (n=7)	−1.5 [−4; 1] (n=6)	−1.0 [−5; 1] (n=7)	1.0 [−4.0; 7.0] p=0.6643	−1.0 [−5.0; 2.0] p=0.4392	1.0 [−2.0; 4.0] p=0.6656
CDR-SOB		0.00 [−1.0; 5.0] (n=6)	0.50 [−2.0; 2.0] (n=7)	0.75 [−1.5; 4.0] (n=6)	0.00 [−2.5; 1.5] (n=7)	−1.25 [−3.50; 0.50] p=0.4236	−0.50 [−2.50; 1.00] p=0.4356	−2.50 [−3.50; 0.00] p=0.0953
ADCS-ADL		−0.5 [−11; 4] (n=6)	−3.0 [−17; 3] (n=7)	−4.0 [−25; 2] (n=6)	2.0 [−6; 10] (n=7)	3.0 [−3.0; 10.0] p=0.3153	5.0 [−1.0; 13.0] p=0.0839	6.5 [0.0; 18.0] p=0.0734
Whole brain volume		−2.0 ± 0.8 (n=5)	−1.5 ± 0.7 (n=6)	−1.4 ± 1.7 (n=5)	−1.4 ± 1.0 (n=4)	0.6 [−0.8; 2.0] p=0.3620	0.1 [−1.1; 1.3] p=0.8766	−0.0 [−2.3; 2.2] p=0.9899
Hippocampal volume left		−166.2 ± 64.0 (n=6)	−183.5 ± 117.4 (n=6)	−131.4 ± 98.0 (n=5)	−216.5 ± 133.2 (n=4)	−50.3 [−193.2; 92.6] p=0.4401	−33.0 [−216.9; 150.9] p=0.6899	−85.1 [−266.6; 96.4] p=0.3042
Hippocampal volume right		−106.2 ± 112.7 (n=6)	−182.2 ± 179.0 (n=6)	−153.6 ± 226.0 (n=5)	−198.3 ± 30.5 (n=4)	−92.1 [−227.6; 43.4] p=0.1557	−16.1 [−228.6; 194.4] p=0.8373	−44.7 [−317.4; 228.1] p=0.6838

Data are mean ± SD (patients analysed) for CSF 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 13 (last infusion at week 22 + 1 day) for 2-week interval and visit 7 (week 20 + 1 day) for 4-week interval