Table 3 Mean changes from baseline on efficacy variables.
| Variable | Rivastigmine TID | Rivastigmine BID | Placebo |
|---|---|---|---|
| Primary | |||
| ADAS‐cog | |||
| ITT population | 277 | 228 | 220 |
| n | |||
| Baseline score | 28.1 (12.5) | 27.7 (12.3) | 28.5 (12.3) |
| Week 26 change | −0.2 (7.3)** | 1.2 (7.2)* | 2.8 (7.2) |
| LOCF population | |||
| n | 209 | 199 | 208 |
| Baseline score | 28.3 (12.2) | 27.7 (12.3) | 28.5 (12.2) |
| Week 26 change | −0.7 (6.9)** | 0.8 (6.9)* | 2.7 (6.8) |
| OC population | |||
| n | 180 | 173 | 183 |
| Baseline score | 27.9 (11.8) | 28.6 (12.1) | 27.7 (11.9) |
| Week 26 change | −0.9 (6.8)** | 0.9 (7.0) | 2.1 (6.8) |
| CIBIC‐Plus | |||
| ITT population | |||
| n | 222 | 222 | 216 |
| Baseline score | – | – | – |
| Week 26 change | 3.9 (1.3)** | 4.1 (1.3)* | 4.5 (1.3) |
| LOCF population | |||
| n | 206 | 198 | 205 |
| Baseline score | – | – | – |
| Week 26 change | 3.9 (1.2)** | 4.1 (1.2)* | 4.5 (1.2) |
| OC population | |||
| n | 177 | 167 | 179 |
| Baseline score | – | – | – |
| Week 26 change | 3.9 (1.2)** | 4.1 (1.2)* | 4.4 (1.2) |
| Secondary | |||
| ADAS‐cogA | |||
| ITT population | |||
| n | 227 | 228 | 220 |
| Baseline score | 29.1 (13.1) | 28.6 (13.0) | 29.4 (13.0) |
| Week 26 change | −0.1 (7.9)** | 1.5 (7.8)* | 3.2 (7.8) |
| LOCF population | |||
| n | 209 | 199 | 208 |
| Baseline score | 29.2 (12.9) | 28.5 (13.0) | 29.4 (12.8) |
| Week 26 change | −0.6 (7.5)** | 1.0 (7.5)* | 3.1 (7.4) |
| PDS | |||
| ITT population | |||
| n | 225 | 227 | 221 |
| Baseline score | 49.2 (19.8) | 48.7 (19.5) | 49.0 (19.6) |
| Week 26 change | −1.5 (11.3)** | −2.6 (11.1)* | −4.9 (11.2) |
| LOCF population | |||
| n | 207 | 195 | 209 |
| Baseline score | 49.0 (19.6) | 48.6 (19.7) | 48.9 (19.4) |
| Week 26 change | −1.0 (11.4)** | −2.3 (11.5)* | −4.7 (11.3) |
| GDS | |||
| ITT population | |||
| n | 227 | 229 | 222 |
| Baseline score | 4.1 (0.9) | 4.0 (0.9) | 4.1 (0.9) |
| Week 26 change | 0.0 (0.7)* | −0.2 (0.7) | −0.3 (0.7) |
| LOCF population | |||
| n | 195 | 188 | 202 |
| Baseline score | 4.1 (0.9) | 4.0 (0.9) | 4.1 (0.9) |
| Week 26 change | −0.0 (0.7)* | −0.1 (0.7) | −0.3 (0.7) |
| MMSE | |||
| ITT population | |||
| n | 227 | 227 | 220 |
| Baseline score | 18.1 (4.7) | 18.8 (4.7) | 18.6 (4.7) |
| Week 26 change | 0.3 (3.6)** | −0.6 (3.6)* | −1.4 (3.6) |
| LOCF population | |||
| n | 193 | 186 | 198 |
| Baseline score | 18.1 (4.5) | 18.7 (4.6) | 18.8 (4.6) |
| Week 26 change | 0.4 (3.4)** | −0.4 (3.5)* | −1.4 (3.5) |
ADAS‐cog, cognitive subscale of the Alzheimer's Disease Assessment Scale; BID, twice daily; CIBIC‐Plus, Clinician Interview Based Impression of Change incorporating caregiver information; GDS, Global Deterioration Scale; ITT, intention to treat; LOCF, last observation carried forward; MMSE, Mini‐Mental State Examination; OC, observed cases; PDS, Progressive Deterioration Scale; TID, three times daily.
CIBIC‐Plus p values based on pairwise t tests using pooled error term from ANOVA (SAS Type III); ADAS‐cog, ADAS‐cogA and PDS p values based on the Mantel–Haenszel test blocking for centre; MMSE and GDS p values based on pairwise t tests using pooled error term from ANCOVA/ANOVA (SAS Type III analysis).
Values are mean (SD).
*p<0.05; **p⩽0.001.