Table 3.
Effects of Cerebrolysin®, donepezil, and combination therapy on plasma neuronal-derived extracellular vesicles (NDEV) biomarkers in AD: Changes from baseline to week 28 (study endpoint)
| Baseline | Week 28 | ||||
| N | Baseline Score (pg/mL) | LS mean change±SE (nL data) | Treatment Difference (95% CI) | p | |
| Aß42 | |||||
| Cerebrolysin® | 37 | 17.10 | –0.079±0.172 | 0.558 (0.061/1.055) | 0.028 |
| Donepezil | 36 | 22.38 | –0.097±0.176 | 0.540 (0.035/1.045) | 0.036 |
| Combination | 35 | 14.90 | –0.638±0.180 | ||
| Total-tau | |||||
| Cerebrolysin® | 37 | 85.78 | –0.141±0.129 | -0.445 (–0.811/–0.079) | 0.018 |
| Donepezil | 35 | 96.37 | 0.304±0.132 | ||
| Combination | 35 | 108.46 | –0.052±0.132 | –0.356 (–0.727/0.015) | 0.060 |
| P-T181-tau | |||||
| Cerebrolysin® | 38 | 45.99 | –0.170±0.108 | –0.374 (–0.683/–0.065) | 0.018 |
| Donepezil | 36 | 53.79 | 0.204±0.112 | ||
| Combination | 36 | 39.23 | –0.158±0.112 | –0.362 (–0.677/–0.046) | 0.025 |
| P-S396-tau | |||||
| Cerebrolysin® | 36 | 25.51 | –0.110±0.132 | –0.261 (–0.638/0.116) | 0.172 |
| Donepezil | 34 | 36.49 | 0.152±0.132 | ||
| Combination | 35 | 25.90 | –0.284±0.134 | –0.435 (–0.814/–0.057) | 0.025 |
| NRGN | |||||
| Cerebrolysin® | 38 | 266.47 | –0.292±0.167 | –0.262 (–0.737/0.213) | 0.277 |
| Donepezil | 36 | 304.39 | –0.031±0.172 | ||
| Combination | 36 | 224.38 | –0.281±0.172 | –0.250 (–0.735/0.234) | 0.308 |
| REST | |||||
| Cerebrolysin® | 37 | 444.88 | –0.049±0.098 | –0.027 (–0.307/0.253) | 0.850 |
| Donepezil | 34 | 480.82 | –0.022±0.102 | ||
| Combination | 35 | 316.01 | –0.104±0.100 | –0.082 (–0.368/0.203) | 0.570 |
Aβ42, amyloid-β 1-42; nL, natural log; NRGN, Neurogranin; P-T181-tau, tau phosphorylated at threonine 181; P-S396-tau, tau phosphorylated at serine 396; REST, repressor element 1-silencing transcription factor. ANCOVA analysis was used.