Table 2.
Mean efficacy assessments at baseline and endpoint (week 24, LOCF; ITT population)
| Outcome measure | N | Baselinea | Endpoint change from baselinea | LSMD [95 % CI] | p-Value |
|---|---|---|---|---|---|
| SIB | |||||
| Memantine ER | 332 | 76.8 ± 17.5 | 2.7 ± 11.2 | 2.6 [1.0, 4.2] | 0.001 |
| Placebo | 327 | 75.2 ± 19.3 | 0.3 ± 11.5 | ||
| CIBIC-Plusb | |||||
| Memantine ER | 333 | 4.5 ± 0.87 | 3.8 ± 1.2b | N/A | 0.008 |
| Placebo | 328 | 4.5 ± 0.82 | 4.1 ± 1.2b | ||
| ADCS–ADL19 | |||||
| Memantine ER | 331 | 33.1 ± 11.1 | −0.7 ± 6.9 | 0.7 [−0.3, 1.8] | 0.177 |
| Placebo | 328 | 32.8 ± 11.0 | −1.3 ± 7.7 | ||
| NPI | |||||
| Memantine ER | 318 | 17.2 ± 15.6 | −4.3 ± 14.6 | −2.7 [−4.5, −0.8] | 0.005 |
| Placebo | 321 | 16.5 ± 15.4 | −1.6 ± 12.7 | ||
| VFT | |||||
| Memantine ER | 330 | 5.8 ± 3.8 | 0.3 ± 2.8 | 0.5 [0.2, 0.9] | 0.004 |
| Placebo | 326 | 5.7 ± 3.7 | −0.3 ± 2.5 | ||
aMean ± standard deviation
bCIBIC-Plus is a categorical measure of change. Values shown for baseline are the Clinician’s Interview-Based Impression of Severity; endpoint values are final CIBIC-Plus scores. p-Value is from a Cochran–Mantel–Haenszel test
ADCS–ADL 19 19-item Alzheimer’s Disease Cooperative Study–Activities of Daily Living, CI confidence interval, CIBIC-Plus Clinician’s Interview-Based Impression of Change Plus Caregiver Input, ER extended-release formulation (28 mg), ITT intent-to-treat, LOCF last observation carried forward, LSMD least squares mean difference, N/A not applicable, NPI Neuropsychiatric Inventory, SIB Severe Impairment Battery, VFT verbal fluency test