Table 4 Plasma biomarker-informed sample size calculations. Tabled values reflect sample size required to detect a 30% difference between treatment and control groups in change from baseline to week 48 on the ADAS-Cog or CDR-SB. Biomarker high and low groups were defined by dividing the cohort at the observed baseline mean value. The total sample size required for an adequately powered 2-group randomized controlled trial is reported
Outcome Measure | ||||
|---|---|---|---|---|
ADAS-Cog | CDR-SB | |||
Inclusion criteria for trial entry | Required n for 80% power | Required n for 90% power | Required n for 80% power | Required n for 90% power |
No biomarker inclusion criteria | 552 | 740 | 518 | 692 |
NfL high (> 29.07 ng/L) | 330 | 442 | 348 | 464 |
NfL low (< = 29.07 ng/L) | 630 | 884 | 694 | 928 |
Aβ42/40 low (< 0.053) | 426 | 568 | 500 | 668 |
Aβ42/40 high (> = 0.053) | 556 | 742 | 538 | 718 |
p-tau181 high (> 4.14 ng/L) | 456 | 610 | 436 | 582 |
p-tau181 low (< = 4.14 ng/L) | 512 | 686 | 584 | 782 |
Aβ42/40 low + p-tau181 high | 404 | 542 | 398 | 532 |
Aβ42/40 high or p-tau181 low | 510 | 682 | 550 | 736 |
Aβ42/40 low + p-tau181 high + NfL high | 276 | 368 | 282 | 376 |
Aβ42/40 low + p-tau181 high + NfL low | 608 | 812 | 690 | 922 |