Table 2.
Baseline characteristics of the patients stratified by 4-week and 2-week dosing interval (Intent-to-treat population; n=55)
| IVIG (n=21) |
Placebo (n=7) |
IVIG (n=20) |
Placebo (n=7) |
|||||
|---|---|---|---|---|---|---|---|---|
| 4-week interval | 2-week interval | |||||||
| 0.2 (n=6) | 0.5 (n=8) | 0.8 (n=7) | 0.1 (n=6) | 0.25 (n=7) | 0.4 (n=7) | |||
| Demographics | ||||||||
| Age (years) | 74.8 ± 5.5 | 65.9 ± 10.2 | 68.4 ± 8.6 | 71.4 ± 11.8 | 66.8 ± 5.5 | 68.3 ± 4.2 | 72.9 ± 5.0 | 72.6 ± 9.2 |
| Women (n) | 2 | 3 | 3 | 5 | 1 | 3 | 3 | 4 |
| White (n) | 5 | 8 | 7 | 6 | 6 | 7 | 7 | 6 |
| Weight (kg) | 72.9 ± 15.9 | 74.8 ± 13.5 | 81.9 ± 13.6 | 65.6 ± 17.9 | 84.8 ± 10.9 | 74.8 ± 14.0 | 77.1 ± 17.6 | 78.1 ± 16.3 |
| Duration of AD (months) | 17.7 ± 16.3 | 17.9 ± 18.3 | 16.0 ± 12.1 | 21.3 ± 16.4 | 38.3 ± 39.6 | 43.8 ± 39.4 | 44.9 ± 15.4 | 25.9 ± 27.6 |
| APOE ε4 carrier | 4 | 3 | 7 | 4 | 6 | 5 | 5 | 6 |
| Use of AChEI or memantine | 5 | 8 | 6 | 5 | 6 | 7 | 5 | 6 |
| Clinical measures | ||||||||
| Modified Hachinski score | 0.3 ± 0.5 | 0.6 ±0.9 | 0.9 ±0.7 | 1.0 ±0.6 | 0.8 ± 0.4 | 0.6±0.5 | 0.1 ±0.4 | 1.0 ±0 |
| GDS | 1.3 ±0.8 | 1.9 ±1.8 | 1.0 ±1.2 | 2.4 ±2.6 | 1.2 ±1.2 | 1.7 ±2.1 | 2.1 ±2.0 | 1.0 ±0.8 |
| MMSE score | 19.3 ± 3.4 | 20.9 ±2.7 | 21.9 ± 2.7 | 22.1 ± 3.1 | 21.8 ±2.6 | 21.4 ±2.4 | 22.4±3.2 | 21.6 ±1.7 |
| ADAS-cog | 27.2 ± 9.7 | 21.0 ± 9.7 | 20.0 ± 9.5 | 21.2 ± 14.7 | 18.5 ± 6.3 | 19.4 ± 8.2 | 17.6 ± 6.5 | 17.7 ± 4.2 |
| CDR - sum of boxes | 6.6 ± 3.3 | 5.1 ± 1.7 | 3.9 ± 2.1 | 5.3 ± 3.7 | 4.4 ± 1.4 | 4.3 ± 1.8 | 4.3 ± 1.1 | 4.8 ± 2.6 |
| ADCS-ADL | 60.5 ± 11.2 | 65.9 ± 8.3 | 67.0 ± 8.3 | 64.4 ± 12.5 | 64.2 ± 6.6 | 65.3 ± 14.0 | 67.1 ± 6.8 | 62.1 ± 10.4 |
| Laboratory measures | ||||||||
| Aβ1–40: CSF (pg/mL) | 8499.2 ± 2030.6 | 8654.6 ± 2357.5 | 7656.0±1882.2 | 10191±2825.4 | 9783.0±2634.0 | 7277.0±2701.1 | 8534.8±3030.3 | 8283.0±2622.3 |
| Plasma (pg/mL) | 169.2 ± 62.7 | 150.9 ± 17.9 | 184.3 ± 43.4 | 194.7 ± 56.5 | 192.5 ± 49.5 | 201.5 ± 37.5 | 189.5 ± 40.6 | 154.1 ± 53.9 |
| Aβ1–42: CSF (pg/mL) | 333.8 ± 156.9 | 279.8 ± 47.5 | 240.0 ± 52.3 | 358.3 ± 161.1 | 355.8 ± 204.5 | 321.4 ± 138.8 | 286.0 ± 101.0 | 369.4 ± 123.5 |
| Plasma (pg/mL) | 42.7 ± 9.4 | 36.6 ± 16.0 | 45.9 ± 8.7 | 42.0 ± 8.5 | 41.8 ± 13.3 | 48.2 ± 12.2 | 39.8 ± 8.7 | 34.3 ± 8.8 |
| Total tau (pg/mL) | 861.3 ± 848.6 | 803.6 ± 239.9 | 629.4 ± 399.3 | 714.9 ± 283.0 | 955.2 ± 327.2 | 468.3 ± 291.5 | 577.2 ± 174.4 | 486.0 ± 182.4 |
| P-tau181 (pg/mL) | 113.8 ± 84.9 | 116.5 ± 27.8 | 91.4 ± 40.9 | 105.9 ± 29.4 | 153.8 ± 68.2 | 77.1 ± 37.1 | 84.8 ± 16.6 | 81.6 ± 22.9 |
| nAbs-Aβ: CSF [RTU] | 7.4 ± 11.9 | 2.2 ± 2.6 | 5.4 ± 6.3 | 4.7 ± 9.2 | 2.1 ± 1.0 | 2.2 ± 2.7 | 2.9 ± 3.1 | 6.9 ± 11.1 |
| Plasma [RTU] | 431.3 ± 161.3 | 493.1 ± 252.7 | 1765.9±3048.1 | 502.1 ± 480.5 | 189.2 ± 72.3 | 562.7 ± 625.1 | 316.0 ± 272.1 | 1086.0±1419.3 |
| Whole brain volume | 1268.2 ± 43.8 | 1319.4 ± 98.1 | 1329.4 ± 90.3 | 1286.3 ± 78.7 | 1276.0 ± 63.0 | 1294.0 ± 47.7 | 1237.1 ± 49.0 | 1265.6 ± 157.9 |
| Hippocampal volume left | 2530.3 ± 387.6 | 2747.6 ± 444.4 | 2568.4 ± 579.9 | 2529.9±353.7 | 2611.0 ± 450.1 | 2818.3 ± 660.9 | 2590.4 ± 392.7 | 2686.6 ± 618.7 |
| Hippocampal volume right | 2693.8 ± 333.9 | 2842.1 ± 557.7 | 2761.9 ± 547.8 | 2679.1±428.4 | 2754.5 ± 609.5 | 2923.6 ± 590.3 | 2969.9 ± 368.2 | 2652.1 ± 474.2 |
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