Table 2.
Primary, Secondary, and Exploratory Outcomes in the mITT Population (N = 238)
| Semorinemab | Placebo | Least square mean difference between groups (95% CI) | Relative reduction, %a | p Value | |||
| n | Adjusted mean (95% CI) | n | Adjusted mean (95% CI) | ||||
| Change from baseline to week 49 in the ADAS-Cog11 | 102 | 3.96 (2.66 to 5.26) | 96 | 6.85 (5.58 to 8.11) | −2.89 (−4.56 to −1.21) | 42.2 | 0.0008 |
| Change from baseline to week 61 in the ADAS-Cog11 | 38 | 5.71 (3.92 to 7.51) | 30 | 8.47 (6.55 to 10.38) | −2.75 (−5.31 to −0.20) | 32.5 | 0.0351 |
| Change from baseline to week 49 in the ADCS-ADL | 107 | −7.63 (−9.61 to −5.66) | 101 | −6.80 (−8.72 to −4.88) | −0.83 (−3.39 to 1.72) | −12.3 | 0.5207 |
| Change from baseline to week 61 in the ADCS-ADL | 40 | −9.29 (−11.95 to −6.63) | 33 | −7.57 (−10.47 to −4.68) | −1.72 (−5.50 to 2.07) | −22.7 | 0.3704 |
| Change from baseline to week 49 in the CDR-SB | 109 | 1.80 (1.37 to 2.23) | 101 | 1.54 (1.12 to 1.96) | 0.26 (−0.29 to 0.82) | −17.2 | 0.3501 |
| Change from baseline to week 61 in the CDR-SB | 40 | 2.45 (1.72 to 3.18) | 33 | 2.28 (1.50 to 3.06) | 0.17 (−0.87 to 1.22) | −7.6 | 0.7431 |
| Change from baseline to week 49 in the MMSE | 105 | −2.86 (−3.51 to −2.21) | 97 | −3.12 (−3.76 to −2.48) | 0.27 (−0.58 to 1.11) | 8.5 | 0.5366 |
| Change from baseline to week 61 in the MMSE | 39 | −3.14 (−4.00 to −2.29) | 29 | −4.22 (−5.14 to −3.30) | 1.08 (−0.15 to 2.30) | 25.5 | 0.0851 |
| Annualized change from baseline in WCG [18F]GTP1 tau PETb | 95 | 0.06 (0.04 to 0.08) | 93 | 0.06 (0.04 to 0.08) | 0.00 (−0.02 to 0.02) | 0.2 | 0.9941 |
Abbreviations: AD = Alzheimer disease; ADAS-Cog = Alzheimer's Disease Assessment Scale-Cognitive Subscale; ADCS-ADL = Alzheimer's Disease Cooperative Study-Activities of Daily Living; CDR-GS = Clinical Dementia Rating Scale-Global Score; CDR-SB = Clinical Dementia Rating Scale-Sum of Boxes; GTP1 = Genentech Tau Probe 1; MMSE = Mini Mental State Examination; WCG = whole cortical gray.
Week 49 analyses include patients from both cohorts; week 61 analyses include only cohort 2 patients. n corresponds to the number of patients at each time point.
Positive relative reduction values indicate differences favoring semorinemab, while negative values indicate differences favoring placebo.
Three patients in the mITT population did not have baseline [18F]GTP1 tau PET (2 in the semorinemab arm and 1 in the placebo arm).