Table 4. Changes From Baseline in Primary End Point in the Full Analysis Setsa.
| Mean ADAS-Cog Total Scoreb | Change From Baseline (95% CI)c |
Mean ADAS-Cog Total Scoreb | Change From Baseline (95% CI)c |
Mean ADAS-Cog Total Scoreb | Change From Baseline (95% CI)c |
Between-Group Difference in Change, Least-Squares Mean (95% CI)d |
P Valuee |
Between-Group Difference in Change, Least-Squares Mean (95% CI)d |
P Valuee |
||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 24 |
Baseline | Week 24 |
Baseline | Week 24 |
||||||||
| Study 1 | Placebo (n = 304) | Idalopirdine (30 mg; n = 310) | Idalopirdine (60 mg; n = 308) | Idalopirdine (30 mg) vs Placebo | Idalopirdine (60 mg) vs Placebo | ||||||||
| 25.8 | 26.2 | 0.41 (−0.28 to 1.11) | 26.7 | 27.1 | 0.61 (−0.09 to 1.32) | 26.3 | 26.4 | 0.37 (−0.32 to 1.06) | 0.33 (−0.59 to 1.26) | .96 | 0.05 (−0.88 to 0.98) | >.99 | |
| Study 2 | Placebo (n = 278) | Idalopirdine (10 mg; n = 282) | Idalopirdine (30 mg; n = 275) | Idalopirdine (10 mg) vs Placebo | Idalopirdine (30 mg) vs Placebo | ||||||||
| 25.7 | 26.1 | 0.56 (−0.18 to 1.30) | 25.9 | 26.3 | 0.53 (−0.22 to 1.27) | 25.3 | 26.2 | 1.01 (0.26 to 1.76) | −0.09 (−1.10 to 0.92)f | 0.63 (−0.38 to 1.65) | .22 | ||
| Study 3 | Placebo (n = 356) | Idalopirdine (60 mg; n = 361) | Idalopirdine (60 mg) vs Placebo | ||||||||||
| 25.9 | 26.6 | 0.82 (0.13 to 1.51) | 26.2 | 26.4 | 0.38 (−0.25 to 1.01) | −0.55 (−1.45 to 0.36) | .24 | ||||||
Abbreviation: ADAS-Cog, 11-item cognitive subscale of the Alzheimer’s Disease Assessment Scale.
Includes patients who received at least 1 dose of treatment and had a valid baseline assessment and at least 1 valid postbaseline assessment of the primary end point.
Range, 0 to 70; a lower score indicates less impairment.
Indicates the observed mean change (ie, only for patients with baseline and week 24 assessments), so it does not match the difference between baseline and week 24 scores.
Indicates the difference in change from baseline to 24 weeks between the placebo and idalopirdine groups. A negative value indicates a treatment effect in favor of idalopirdine.
Adjusted P values that are computed as the smallest significance levels at which one can reject the associated tests under the prespecified test hierarchies.
Between-group statistical comparison was not performed due to the null findings of the 30-mg dose of idalopirdine vs placebo and the prespecified gated testing strategy that allowed statistical testing of the 10-mg dose of idalopirdine vs placebo only if findings with the 30-mg dose were statistically significant.