Table 1.
Baseline characteristics of the patients (Full Analysis Set = Intent-to-treat population; n=55).
| IVIG (n=41) | Placebo (n=14) | |
|---|---|---|
| Demographics | ||
| Age (years; mean ±SD) | 69.4 ± 7.3 | 72.0 ± 10.2 |
| Women n (%) | 15 (36.6) | 9 (64.3) |
| White n (%) | 40 (97.6) | 12 (85.7) |
| Weight (kg ±SD) | 77.6 ± 14.1 | 71.8 ± 17.7 |
| Duration of symptoms of AD (months; mean ±SD) |
29.6 ± 27.3 | 23.6 ± 21.9 |
| APOE ε4 carrier n (%) | 30 (73.2) | 10 (71.4) |
| Use of AChEI or memantine n (%) | 36 (87.8) | 11 (78.6) |
| Clinical measures | ||
| Modified Hachinski score (mean ±SD) | 0.6 ± 0.6 | 1.0 ± 0.4 |
| GDS (mean ±SD) | 1.6 ± 1.5 | 1.7 ± 2.0 |
| MMSE score (mean ±SD) | 21.3 ± 2.8 | 21.9 ± 2.4 |
| ADAS-cog (mean ±SD) | 20.5 ± 8.5 | 19.5 ± 10.5 |
| Clinical dementia rating - sum of boxes (mean ±SD) |
4.7 ± 2.0 | 5.0 ± 3.1 |
| ADCS-ADL (mean ±SD) | 65.1 ± 9.2 | 63.3 ± 11.1 |
| Laboratory measures | ||
| Aβ1–40: CSF (pg/mL) | 8366.8 ± 2428.3 | 9237.0 ± 2799.7 |
| Plasma (pg/mL) | 180.6 ± 43.9 | 174.4 ± 57.1 |
| Aβ1–42: CSF (pg/mL) | 300.6 ± 122.9 | 363.9 ± 138.0 |
| Plasma (pg/mL) | 42.3 ± 11.8 | 38.1 ± 9.2 |
| Tau [pg/ml] | 711.9 ± 432.2 | 600.4 ± 257.7 |
| Tau181 [pg/ml] | 105.7 ± 53.0 | 93.7 ± 28.3 |
| nAbs-Aβ: CSF[RTU] | 3.6 ± 6.7 | 5.8 ± 9.9 |
| Plasma [RTU] | 646.6 ± 1342.2 | 794.1 ± 1062.1 |
| Microbleeds n (%) | 8 (19.5) | 1 (7.1) |
| Normalized whole brain volume | 1288.9 ± 73.3 | 1275.9 ± 120.3 |
| Hippocampal volume left [mm3] | 2650.5 ± 478.3 | 2608.2 ± 491.0 |
| Hippocampal volume right [mm3] | 2829.6 ± 491.8 | 2665.6 ± 434.3 |
Data are number (%) or mean (SD); MMSE: Mini-Mental State Examination; APOE ε4: Apolipoprotein E ε4; AChEI: Acetylcholinesterase Inhibitor; ADAS-cog: Alzheimer's Disease Assessment Scale-cognitive subscale. GDS: Geriatric Depression Scale; ADCS-ADL: Alzheimer’s Disease Cooperative Study - Activities of Daily Living Inventory.