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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.