Table 1 |.
Demographic and baseline characteristics of the study participants
| DIAN-TU-001 mutation carriers | DIAN-OBS mutation carriers | |||
|---|---|---|---|---|
| Active gantenerumab n = 52 | Active solanezumaba n = 50 | Shared placebo n = 40 | DIAN-OBSb controls n = 69 | |
| Age (years) | 46.0 ± 10.8 | 42.5 ± 9.5 | 44.2 ± 9.6 | 42.3 ± 9.6 |
| Female (n (%)) | 21 (40) | 29 (58) | 22 (55) | 47 (68) |
| Gene (n (%)) | ||||
| APP | 6 (12) | 8 (16) | 5 (13) | 10 (14) |
| PS1 | 43 (83) | 40 (80) | 32 (80) | 55 (80) |
| PS2 | 3 (6) | 2 (4) | 3 (8) | 4 (6) |
| APOE4c (n (%)) | 16 (31) | 14 (28) | 13 (32) | 18 (26) |
| Enrollment EYO | −3.5 ± 7.1 | −2.4 ± 7.1 | −3.5 ± 7.6 | −3.6 ± 6.9 |
| CDRd 0 (n (%)) | 31 (60) | 30 (60) | 22 (55) | 35 (51) |
| CDR 0.5 (n (%)) | 15 (29) | 13 (26) | 15 (38) | 27 (39) |
| CDR 1 (n (%)) | 6 (12) | 7 (14) | 3 (8) | 7 (10) |
| Digit symbole | 46.96 ± 20.56 | 46.06 ± 19.94 | 46.63 ± 19.12 | 50.34 ± 18.57 |
| MMSEf | 27.10 ± 3.45 | 26.72 ± 4.11 | 26.68 ± 3.97 | 26.96 ± 3.22 |
| Logical memoryg | 9.90 ± 6.33 | 9.86 ± 6.86 | 9.40 ± 6.45 | 9.32 ± 6.42 |
| ISLTh | 5.96 ± 4.04 | 6.56 ± 3.95 | 5.80 ± 4.42 | NA |
| CDR-SBi | 1.33 ± 2.08 | 1.37 ± 2.01 | 1.43 ± 1.87 | 1.19 ± 1.70 |
| Amyloid burden (PiB-PET composite SUVR)j | 2.64 ± 1.23 | 2.75 ± 1.32 | 2.62 ± 1.20 | 2.39 ± 1.12 |
| Amyloid burden (Centiloid) | 64.75 ± 51.87 | 66.56 ± 54.11 | 63.97 ± 49.46 | 51.57 ± 46.78 |
Plus-minus values are the mean ± s.d.
Fifty-two participants were randomized to the solanezumab arm; 2 did not have post-baseline data and were excluded from the modified intent-to-treat population.
Excludes 54 run-in participants previously enrolled in DIAN–OBS who transitioned to the DIAN–Tu-001 trial; therefore, their demographic data are included in the DIAN–Tu active groups.
APOE refers to presence of at least one ε4 allele of apolipoprotein E.
CDR scores range from 0 to 3, with higher scores indicating worse cognition and daily function.
Digit Symbol scores range from 0 to 93, with lower scores indicating poorer cognitive performance.
MMSE scores range from 0 to 30, with lower scores indicating poorer cognitive performance.
Logical Memory scores range from 0 to 25, with lower scores indicating poorer cognitive performance.
ISLT scores range from 0 to 12, with lower scores indicating poorer cognitive performance.
CDR-SB scores range from 0 to 18, with higher scores indicating worse cognition and daily function.
PiB-PET composite SuVR refers to brain amyloid burden measured by the average SuVR of cortical regions of interest (superior frontal, rostral middle frontal, superior temporal, middle temporal, lateral orbitofrontal, medial orbitofrontal and precuneus), assessed by PiB-PET. NA, not applicable.