TABLE 2.
Primary and secondary efficacy outcomes at end of double‐blind treatment period, week 24 (mITT population)
| Adjusted mean through week 24 | Pairwise comparison | ||||||
|---|---|---|---|---|---|---|---|
| n | Placebo | n | Intepirdine | Difference | 95% CI | P‐value | |
| Primary endpoints | |||||||
| ADAS‐Cog change from baseline | 577 | 0.75 (0.21) | 584 | 0.39 (0.21) | −0.36 (0.30) | −0.95, 0.22 | 0.2249 |
| ADCS‐ADL change from baseline | 575 | −0.97 (0.29) | 588 | −1.06 (0.29) | −0.09 (0.41) | −0.90, 0.72 | 0.8260 |
| Secondary endpoints | |||||||
| CIBIC+ | 568 | 4.30 (0.037) | 577 | 4.18 (0.037) | −0.12 (0.051) | −0.22, −0.02 | 0.0234 |
| DS Total Score change from baseline | 568 | 0.17 (0.071) | 580 | 0.30 (0.070) | 0.12 (0.10) | ‐0‐.07, 0.32 | 0.2096 |
| NPI Total Score change from baseline | 570 | 0.06 (0.34) | 583 | −0.08 (0.34) | −0.14 (0.48) | −1.09, 0.80 | 0.7650 |
| ADAS‐Cog‐13 change from baseline | 576 | 0.64 (0.24) | 583 | 0.26 (0.23) | −0.38 (0.33) | −1.03, 0.27 | 0.2472 |
A total of 633 placebo‐treated patients and 643 intepirdine‐treated patients made up the mITT population. The co‐primary endpoints, ADAS‐Cog and ADCS‐ADL, and the secondary endpoints, DS Total Score, NPI Total Score, and ADAS‐Cog‐13, were not statistically different between the intepirdine and placebo groups. The secondary endpoint CIBIC+ demonstrated a statistically significant improvement favoring intepirdine over placebo. Treatment comparisons were based on a mixed model for repeated measures. SE are in parentheses. n = number of patients with measurement of the indicated endpoint at week 24
Abbreviations: ADAS‐Cog, Alzheimer's Disease Assessment Scale‐Cognitive Subscale; ADCS‐ADL, Alzheimer's Disease Cooperative Study‐Activities of Daily Living; CIBIC+, Clinician's Interview‐Based Impression of Change plus caregiver interview; DS, Dependence Scale; NPI, Neuropsychiatric Inventory; mITT, modified intent‐to‐treat; SE, standard error.