Table 2.
Primary (SIB and ADCS‐ADL‐SIV) and secondary (ADCS‐CGIC and NPI‐12) efficacy outcomes (modified full analysis set)
| 13.3 mg/24 h rivastigmine patch | 4.6 mg/24 h rivastigmine patch | P‐value | |
|---|---|---|---|
| N = 338 | N = 335 | ||
| SIB | |||
| N (baseline) | 336 | 334 | |
| Mean (SD) score at baseline | 69.3 (21.5) | 68.3 (22.8) | |
| N (Week 24) | 313 | 316 | |
| Mean (SD) change from baseline at Week 24 | −1.6 (13.5) | −6.4 (14.0) | |
| Least‐squares means (SE) change from baseline at Week 24 | −1.7 (0.8) | −6.6 (0.8) | |
| Least‐squares means difference (95% CI) | 4.9 (2.8, 7.0) | <0.0001 | |
| ADCS‐ADL‐SIV | |||
| N (baseline) | 333 | 319 | |
| Mean (SD) score at baseline | 29.7 (11.3) | 29.1 (11.9) | |
| N (Week 24) | 310 | 303 | |
| Mean (SD) change from baseline at Week 24 | −2.6 (6.8) | −3.6 (7.7) | |
| Least‐squares means (SE) change from baseline at Week 24 | −2.4 (0.4) | −3.6 (0.4) | |
| Least‐squares means difference (95% CI) | 1.2 (0.2, 2.3) | 0.0247 | |
| ADCS‐CGIC | |||
| Week 24, n (%) | 0.0023 | ||
| Marked improvement | 3 (1.0) | 4 (1.3) | |
| Moderate improvement | 11 (3.5) | 11 (3.5) | |
| Minimal improvement | 63 (20.1) | 36 (11.4) | |
| No change | 107 (34.2) | 92 (29.2) | |
| Minimal worsening | 76 (24.3) | 99 (31.4) | |
| Moderate worsening | 44 (14.1) | 60 (19.0) | |
| Marked worsening | 9 (2.9) | 13 (4.1) | |
| NPI‐12 | |||
| N (baseline) | 335 | 331 | |
| Mean (SD) score at baseline | 17.3 (15.4) | 16.8 (16.7) | |
| N (Week 24) | 313 | 313 | |
| Mean (SD) change from baseline at Week 24 | −0.4 (14.0) | 1.2 (16.8) | |
| Least‐squares means (SE) change from baseline at Week 24 | −0.1 (0.8) | 1.5 (0.8) | |
| Least‐squares means difference (95% CI) | −1.6 (−3.8, 0.6) | 0.1437 | |
ADCS‐ADL‐SIV, Alzheimer's Disease Cooperative Study–Activities of Daily Living scale–Severe Impairment Version; ADCS‐CGIC, Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change; CI, confidence interval; N, number of patients with an assessment at the given time point; n, number of patients in a given category; NPI‐12, 12‐item Neuropsychiatric Inventory; SD, standard deviation; SE, standard error; SIB, Severe Impairment Battery.