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Table 1 Outcomes by treatment arms a

From: Peripheral and central effects of γ-secretase inhibition by semagacestat in Alzheimer’s disease

  Placebo LY 100 mg LY 140 mg P -value
Annualized change in ADASCog11 4.75 ± 21.92 (n = 485) 6.57 ± 25.57 (n = 482) 5.48 ± 21.92 (n = 495) 0.408
Annualized change in MMSE −2.19 ± 3.65 (n = 396) −2.56 ± 3.65 (n = 324) −2.92 ± 3.65 (n = 303) 0.159
Annualized change in FDG-PET SUVR −0.06 ± 0.07 (n = 40) −0.13 ± 0.21 (n = 42) −0.1 ± 0.08 (n = 33) 0.109
Annualized change in AV45 SUVR 0.05 ± 0.11 (n = 18) 0.02 ± 0.24 (n = 23) 0.07 ± 0.23 (n = 18) 0.794
Annualized change in ventricular volume 4.07 ± 3.52 (n = 80) 4.19 ± 3.92 (n = 74) 5.68 ± 4.68 (n = 67) 0.033
Annualized change in right hippocampal volume −86.28 ± 73.86 (n = 74) −91.08 ± 102.1 (n = 68) −90.98 ± 71.1 (n = 64) 0.926
Annualized change in left hippocampal volume −68.85 ± 59.01 (n = 74) −70.4 ± 90.81 (n = 68) −91.0 ± 101.2 (n = 64) 0.244
Annualized change in CSF Aβ40 87.66 ± 847 (n = 10) −10.96 ± 1151 (n = 19) −599 ± 1786 (n = 18) 0.328
Annualized change in CSF Aβ42 10.96 ± 87.66 (n = 10) −40.18 ± 109.6 (n = 19) −36.5 ± 182.7 (n = 18) 0.619
Annualized change in p-tau 10.96 ± 7.31 (n = 10) −7.31 ± 14.61 (n = 19) −3.65 ± 10.96 (n = 18) 0.009
Annualized change in total tau 94.97 ± 116.9 (n = 10) −43.83 ± 219.2 (n = 17) 40.18 ± 127.8 (n = 18) 0.101
Percentage change in plasma Aβ40 at week 52 4.77 ± 26.67 (n = 307) −37.54 ± 109.3 (n = 264) −47.76 ± 32.06 (n = 243) <0.001
Percentage change in plasma Aβ42 at week 52 3.82 ± 20.75 (n = 309) −5.4 ± 53.1 (n = 265) −18.14 ± 33.0 (n = 245) <0.001
Change in uric acid at week 76 0.18 ± 0.83 (n = 210) −0.96 ± 1.08 (n = 179) −0.88 ± 1.22 (n = 147) <0.001
Change in albumin at week 76 0 ± 0.25 (n = 210) −0.09 ± 0.31 (n = 179) −0.09 ± 0.3 (n = 147) 0.002
Change in eosinophils at week 76 −0.001 ± 0.09 (n = 207) 0.05 ± 0.17 (n = 179) 0.06 ± 0.14 (n = 143) <0.001
Gastrointestinal symptoms 153 (31.5%) 169 (34.9%) 193 (38.8%) 0.057
Skin disorder incidence 105 (21.6%) 220 (45.4%) 269 (54%) <0.001
Skin cancer incidence 8 (1.7%) 51 (10.5%) 56 (11.2%) <0.001
Infection incidence 156 (32.1%) 188 (38.8%) 220 (44.2%) <0.001
AUC   5,316 ± 1,525 (n = 480) 7,235 ± 2233 (n = 494) <0.001
Cmax   1,105 ± 260 (n = 480) 1,508 ± 384 (n = 494) <0.001
  1. aAβ40, Amyloid-β peptide 40; Aβ42, Amyloid-β peptide 42; ADAScog11, Alzheimer’s Disease Assessment Scale–Cognitive Subscale, 11-item version; AUC, Area under the curve; AV45, Florbetapir; Cmax, Maximum concentration; CSF, Cerebrospinal fluid; FDG-PET, Fludeoxyglucose positron emission tomography; LY, Semagacestat; MMSE, Mini Mental State Examination; p-tau, Phosphorylated tau; SUVR, Standard uptake value ratio.