TABLE 1.
Baseline characteristics of all randomized participants and participants with 36‐month data eligible for efficacy analyses
| All randomized participants | Participants with 36‐month data eligible for efficacy analyses | |||
|---|---|---|---|---|
| Control (n = 158) | Active (n = 153) | Control (n = 36) | Active (n = 45) | |
| Age (years) | ||||
| Mean (SD) | 70.7 (6.2) | 71.3 (7.0) | 69.9 (6.6) | 71.9 (7.2) |
| Median (min ‐ max) | 71 (52 to 84) | 72 (50 to 86) | 71 (54 to 84) | 72 (56 to 85) |
| Sex, no. (%) | ||||
| Men | 73 (46%) | 81 (53%) | 19 (53%) | 25 (56%) |
| Women | 85 (54%) | 72 (47%) | 17 (47%) | 20 (44%) |
| Ethnic origin, no. (%) | ||||
| White | 157 (99%) | 152 (99%) | 36 (100%) | 44 (98%) |
| Black | 0 (0%) | 1 (1%) | 0 (0%) | 1 (2%) |
| Other | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Education (years) | 10.7 (3.6) | 10.6 (3.9) | 11.4 (3.8) | 10.5 (3.8) |
| Mini‐Mental State Examination | 26.9 (1.9) | 26.4 (2.1)a | 27.7 (1.7) | 27.2 (2.0) |
| APOE ɛ4 genotypeb, n/N (%) | ||||
| Carrier | 90/143 (63%) | 83/138 (60%) | 22/33 (67%) | 21/42 (50%) |
| Non‐carrier | 53/143 (37%) | 55/138 (40%) | 11/33 (33%) | 21/42 (50%) |
| Cognitive measures (composite Z score) | ||||
| NTB 5‐item | 0.00 (0.68) [156] | −0.00 (0.70) [152] | 0.20 (0.67) [36] | 0.40 (0.50) [45] |
| NTB memory domain | 0.03 (0.82) [156] | −0.02 (0.87) [151] | 0.19 (0.79) [36] | 0.47 (0.61) [44] |
| NTB executive function | −0.01 (0.71) [155] | 0.01 (0.71) [150] | 0.17 (0.68) [35] | 0.27 (0.64) [44] |
| NTB total | −0.02 (0.56) [156] | 0.02 (0.57) [151] | 0.19 (0.52) [36] | 0.33 (0.48) [44] |
| CDR‐SB | 1.75 (1.14) [143] | 1.87 (1.17) [140] | 1.05 (0.78) [32] | 1.18 (0.88) [42] |
| MRI brain volumes (cm3)c | ||||
| Total hippocampal volume | 5.70 (1.25) [115] | 5.62 (1.10) [102] | 5.93 (1.36) [29] | 6.06 (1.10) [37] |
| Whole brain volume | 1377.30 (84.08) [101] | 1370.56 (81.64) [89] | 1438.59 (93.92) [23] | 1398.13 (83.55) [32] |
| Ventricular volume | 53.95 (25.31) [123] | 58.35 (26.66) [114] | 47.27 (22.92) [28] | 50.62 (24.05) [34] |
| CSFc | ||||
| Aβ‐42 (pg/mL) | 401.1 (196.1) | 426.9 (292.7) | 482.8 (232.0) | 626.2 (365.0) |
| (Aβ‐42/Aβ‐40) × 10 | 0.62 (0.25) | 0.65 (0.29) | 0.69 (0.27) | 0.86 (0.32) |
| Total‐tau (pg/mL) | 634.8 (287.7) | 591.9 (260.9) | 603.6 (230.6) | 467.8 (172.5) |
| Phospho‐tau (pg/mL) | 80.3 (30.6) | 74.2 (25.8) | 79.7 (26.9) | 63.6 (21.1) |
Data are mean (SD) or mean (SD) [N] unless stated otherwise.
Slight but statistically significant lower Mini‐Mental State Examination score in the active versus control group (P = 0.038, t test). There were no other statistically significant baseline differences between the active and control groups, both within the all‐randomized participants and the participants with 36‐month data eligible for efficacy analysis.
Data not available for all randomized participants. Percentages are calculated based on number of participants with available data.
Central analysis CSF data available for n = 107 (all randomized participants; control n = 61, active n = 46) and n = 32 (participants with 36‐month data in the mITT analyses; control n = 15, active n = 17); central analyses MRI data available for n = 279 and n = 75, respectively).
Abbreviations: Aβ, amyloid beta; APOE, apolipoprotein E; CDR‐SB, Clinical Dementia Rating‐Sum of Boxes; CSF, cerebrospinal fluid; MRI, magnetic resonance imaging; NTB, Neuropsychological Test Battery; SD, standard deviation.