Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 2 | |||
Summary Statisticsa | |||
n | 84 | 78 | 78 |
Mean | -0.123 | -0.097 | -0.223 |
SE | 0.059 | 0.056 | 0.060 |
Median | -0.129 | -0.103 | -0.181 |
Q1, Q3 | -0.465, 0.065 | -0.414, 0.259 | -0.569, 0.181 |
Min, Max | -1.09, 3.05 | -1.76, 1.14 | -1.76, 0.80 |
LS Meanb | |||
Estimate (SE) | -0.123 (0.058) | -0.115 (0.059) | -0.218 (0.059) |
95% CI | (-0.236, -0.009) | (-0.232, 0.002) | (-0.335, -0.101) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | 0.008 (0.083) | -0.095 (0.083) |
95% CI | (-, -) | (-0.155, 0.171) | (-0.258, 0.068) |
Nominal p-value | - | 0.9206 | 0.2535 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 4 | |||
Summary Statisticsa | |||
n | 82 | 70 | 72 |
Mean | -0.241 | -0.206 | -0.260 |
SE | 0.063 | 0.059 | 0.060 |
Median | -0.233 | -0.142 | -0.284 |
Q1, Q3 | -0.672, 0.052 | -0.465, 0.103 | -0.556, 0.078 |
Min, Max | -1.42, 2.25 | -1.66, 0.91 | -1.47, 1.11 |
LS Meanb | |||
Estimate (SE) | -0.239 (0.058) | -0.216 (0.062) | -0.269 (0.061) |
95% CI | (-0.354, -0.124) | (-0.338, -0.094) | (-0.390, -0.148) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | 0.023 (0.085) | -0.029 (0.085) |
95% CI | (-, -) | (-0.145, 0.191) | (-0.196, 0.138) |
Nominal p-value | - | 0.7873 | 0.7298 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 6 | |||
Summary Statisticsa | |||
n | 75 | 62 | 67 |
Mean | -0.127 | -0.205 | -0.269 |
SE | 0.078 | 0.070 | 0.078 |
Median | -0.129 | -0.168 | -0.362 |
Q1, Q3 | -0.595, 0.259 | -0.491, 0.078 | -0.621, 0.259 |
Min, Max | -1.29, 3.10 | -1.91, 1.22 | -1.94, 1.06 |
LS Meanb | |||
Estimate (SE) | -0.139 (0.071) | -0.230 (0.076) | -0.292 (0.074) |
95% CI | (-0.279, 0.000) | (-0.379, -0.081) | (-0.438, -0.147) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.091 (0.104) | -0.153 (0.102) |
95% CI | (-, -) | (-0.295, 0.113) | (-0.355, 0.049) |
Nominal p-value | - | 0.3807 | 0.1360 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 8 | |||
Summary Statisticsa | |||
n | 73 | 58 | 56 |
Mean | -0.238 | -0.218 | -0.271 |
SE | 0.083 | 0.064 | 0.072 |
Median | -0.259 | -0.246 | -0.336 |
Q1, Q3 | -0.621, 0.181 | -0.543, 0.052 | -0.556, 0.142 |
Min, Max | -2.87, 1.66 | -1.58, 0.80 | -2.61, 0.78 |
LS Meanb | |||
Estimate (SE) | -0.209 (0.072) | -0.245 (0.079) | -0.294 (0.079) |
95% CI | (-0.350, -0.067) | (-0.400, -0.090) | (-0.450, -0.139) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.037 (0.106) | -0.086 (0.107) |
95% CI | (-, -) | (-0.247, 0.173) | (-0.296, 0.125) |
Nominal p-value | - | 0.7300 | 0.4227 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 12 | |||
Summary Statisticsa | |||
n | 67 | 50 | 50 |
Mean | -0.221 | -0.315 | -0.324 |
SE | 0.070 | 0.067 | 0.090 |
Median | -0.155 | -0.297 | -0.349 |
Q1, Q3 | -0.621, 0.207 | -0.647, 0.000 | -0.621, 0.155 |
Min, Max | -1.94, 1.03 | -1.45, 0.88 | -2.97, 0.65 |
LS Meanb | |||
Estimate (SE) | -0.212 (0.068) | -0.366 (0.076) | -0.344 (0.076) |
95% CI | (-0.347, -0.077) | (-0.515, -0.216) | (-0.493, -0.195) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.154 (0.102) | -0.132 (0.102) |
95% CI | (-, -) | (-0.355, 0.048) | (-0.333, 0.069) |
Nominal p-value | - | 0.1338 | 0.1974 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 16 | |||
Summary Statisticsa | |||
n | 68 | 40 | 37 |
Mean | -0.114 | -0.267 | -0.238 |
SE | 0.071 | 0.076 | 0.090 |
Median | -0.181 | -0.233 | -0.284 |
Q1, Q3 | -0.465, 0.259 | -0.608, 0.013 | -0.543, 0.000 |
Min, Max | -1.50, 1.11 | -1.27, 1.14 | -1.34, 0.98 |
LS Meanb | |||
Estimate (SE) | -0.095 (0.067) | -0.306 (0.081) | -0.322 (0.083) |
95% CI | (-0.227, 0.037) | (-0.467, -0.146) | (-0.486, -0.158) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.211 (0.105) | -0.227 (0.107) |
95% CI | (-, -) | (-0.419, -0.003) | (-0.438, -0.017) |
Nominal p-value | - | 0.0463 | 0.0347 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 20 | |||
Summary Statisticsa | |||
n | 66 | 30 | 31 |
Mean | -0.248 | -0.412 | -0.279 |
SE | 0.083 | 0.083 | 0.087 |
Median | -0.310 | -0.323 | -0.336 |
Q1, Q3 | -0.672, 0.207 | -0.802, -0.078 | -0.621, 0.129 |
Min, Max | -1.81, 1.40 | -1.27, 0.31 | -1.60, 0.80 |
LS Meanb | |||
Estimate (SE) | -0.219 (0.073) | -0.455 (0.095) | -0.401 (0.094) |
95% CI | (-0.363, -0.075) | (-0.642, -0.268) | (-0.586, -0.217) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.235 (0.119) | -0.182 (0.118) |
95% CI | (-, -) | (-0.471, 0.001) | (-0.416, 0.052) |
Nominal p-value | - | 0.0506 | 0.1264 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 24 | |||
Summary Statisticsa | |||
n | 57 | 26 | 30 |
Mean | -0.343 | -0.215 | -0.259 |
SE | 0.090 | 0.127 | 0.092 |
Median | -0.233 | -0.103 | -0.310 |
Q1, Q3 | -0.750, 0.181 | -0.569, 0.155 | -0.569, 0.181 |
Min, Max | -2.30, 1.16 | -1.81, 1.50 | -1.60, 0.75 |
LS Meanb | |||
Estimate (SE) | -0.323 (0.080) | -0.224 (0.110) | -0.362 (0.104) |
95% CI | (-0.482, -0.163) | (-0.440, -0.007) | (-0.568, -0.156) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | 0.099 (0.136) | -0.039 (0.132) |
95% CI | (-, -) | (-0.170, 0.368) | (-0.300, 0.221) |
Nominal p-value | - | 0.4679 | 0.7656 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |
Placebo (N = 86) |
Xanomeline Low Dose (N = 84) |
Xanomeline High Dose (N = 84) |
|
---|---|---|---|
Week 26 | |||
Summary Statisticsa | |||
n | 57 | 24 | 27 |
Mean | -0.275 | -0.394 | -0.180 |
SE | 0.082 | 0.131 | 0.155 |
Median | -0.233 | -0.349 | -0.233 |
Q1, Q3 | -0.776, 0.181 | -0.905, -0.091 | -0.672, 0.155 |
Min, Max | -1.63, 0.98 | -1.34, 1.01 | -2.33, 1.45 |
LS Meanb | |||
Estimate (SE) | -0.257 (0.084) | -0.359 (0.116) | -0.286 (0.111) |
95% CI | (-0.424, -0.090) | (-0.589, -0.130) | (-0.505, -0.067) |
Treatment Difference (Active-Placebo) | |||
Estimate (SE) | - (-) | -0.102 (0.144) | -0.029 (0.139) |
95% CI | (-, -) | (-0.386, 0.181) | (-0.304, 0.247) |
Nominal p-value | - | 0.4768 | 0.8368 |
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. aSummary statistics are based on observed data. bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit. |