Table 3 Number of participants to enroll and screen for future AD clinical trials. The sample size calculation was based on the LME models for subjects positive to amyloid-PET combined with tau-PET and/or plasma biomarkers positivity. The number of participants per arm was estimated for several percentages of cognitive decline slowing (measured as MMSE points/year) and the number of participants to screen were also calculated based on the positivity rate for each biomarker
Positivity based on | Linear mixed effect models | Number of participants per arm according to the % of cognitive decline slowing (number of participants to screen) | ||||||
|---|---|---|---|---|---|---|---|---|
N out of 39 amy-positive MCI participants | Inter-subject variability of random slope | Residual variance | Random slope (cognitive decline) | 20% | 30% | 40% | 50% | |
Amy-PET | 39 (100%) | 0.68 | 2.02 | -1.07 | 375 (375) | 167 (167) | 94 (94) | 60 (60) |
Amy-PET/NfL | 14 (36%) | 0.55 | 1.92 | -2.14 | 85 (236) | 38 (106) | 21 (58) | 14 (39) |
Amy-PET/GFAP | 23 (59%) | 0.61 | 1.97 | -1.47 | 188 (319) | 84 (142) | 47 (80) | 30 (51) |
Amy-PET/NfL/GFAP | 12 (31%) | 0.56 | 1.94 | -2.13 | 86 (277) | 38 (123) | 22 (71) | 14 (45) |
Amy-PET/Tau-PET | 19 (49%) | 0.68 | 1.9 | -1.36 | 226 (461) | 100 (204) | 56 (114) | 36 (100) |
Amy-PET/Tau-PET/NfL | 11 (28%) | 0.51 | 1.92 | -2.05 | 89 (317) | 39 (139) | 22 (79) | 14 (50) |
Tau-PET/GFAP | 13 (33%) | 0.57 | 1.98 | -1.69 | 138 (418) | 61 (185) | 35 (106) | 22 (67) |
Tau-PET/NfL/GFAP | 10 (26%) | 0.52 | 1.94 | -2.02 | 93 (358) | 41 (158) | 23 (88) | 15 (58) |