Table 3.
Biomarkers analyzed at baseline, visit 4 (day 63), visit 5 (day 180) and visit 6 (day 300)
| Outcome measures mean±SD (median; range; N) | Baseline | V4 | V5 | V6 | p-value baseline-V4 | p-value baseline-V5 | p-value baseline-V6 |
| βAmyloid 1–42 [pg/ml] | 795.06±308.55 | 825.26±262.74 | 811.35±304.24 | 838.87±280.35 | 0.705 | 0.721 | 0.688 |
| (786.73; 292.71–1470.00; 18) | (851.13; 360.28–1240.00; 19) | (784.87; 149.09–1570.00; 17) | (736.15; 459.68–1616.00; 16) | ||||
| βAmyloid 1–40 [pg/ml] | 10762.33±4296.74 | 11064.84±3080.05 | 10916.12±3583.42 | 11109.44±3612.89 | 0.863 | 0.672 | 0.771 |
| (11391.00; 1939.00–19171.00; 18) | (10560.00; 5940.00–16732.00; 19) | (10535.00; 3870.00–18324.00; 17) | (10836.50; 6214.00–21513.00; 16) | ||||
| TAU-protein [pg/ml] | 155.56±64.50 | 154.74±62.01 | 171.99±85.43 | 183.87±77.30 | 0.979 | 0.645 | 0.320 |
| (135.91; 100.00–364.20; 17) | (141.29; 100.00–366.66; 19) | (149.57; 100.00–450.69; 15) | (151.01; 119.08–421.50; 15) | ||||
| pTAU-protein [pg/ml] | 56.29±32.75 | 43.33±11.19 | 44.23±15.87 | 40.49±12.13 | 0.035 | 0.016 | |
| (46.88; 18.96–129.94; 17) | (43.36; 23.45–70.24; 18) | (44.31; 23.05–90.06; 16) | (36.28; 28.67–76.15; 15) | d = 0.5; r = 0.26 | 0.103 | d = 0.6; r = 0.31 | |
| NSE [ng/ml] | 10.96±3.20 | 10.36±4.00 | 9.88±4.16 | 9.43±2.76 | 0.013 | 0.007 | 0.005 |
| (10.40; 7.80–17.10; 11) | (8.00; 6.60–19.40; 17) | (7.60; 6.10–1940; 16) | (8.20; 6.30–14.40; 15) | d = 0.2; r = 0.08 | d = 0.3; r = 0.14 | d = 0.5; r = 0.25 | |
| pNfH [pg/ml] | <62,5 in all patients | <62,5 in all patients | <62,5 in all patients | 306.25±381.86 | |||
| (98.0; 63–966; 17) | n/a | n/a | n/a | ||||
| Protenis [mg/dl] | 37.39±12.07 | 38.05±11.62 | 40.41±15.51 | 41.07±13.26 | 0.141 | 0.053 | 0.31 |
| (34.00; 19.00–60.00; 18) | (34.00; 20.00–60.00; 19) | (36.00; 22.00–82.00; 17) | (43.00; 22.00–65.00; 15) | d = 0.2; r = 0.11 | d = 0.3; r = 0.14 | ||
| CK [U/l] | 448.68±375.74 | 419.00±307.30 | 486.12±354.40 | 490.25±358.13 | |||
| (350.00; 68.00–1419.00; 19) | (357.00; 70.00–1203.00; 19) | (413.00; 99.00–1321.00; 17) | (424.50; 98.00–1418.00; 16) | 0.445 | 0.861 | 0.644 |
pg = picograms, ml = millilitres, ng = nanogram, U = Units, l = liter, d = Cohen’s d, r = effect size r, pTAU-protein = phosphorylated Tau-protein, NSE = neuron-specific enolase, pNfH = phosphorylated neurofilaments heavy chain, CK = creatinekinase.