|
Assessment
|
Parameter
|
PBO
|
MEM
|
PBO-DON
|
MEM-DON
|
|---|
| |
number = 281
|
number = 289
|
number = 418
|
number = 429
|
|---|
|
SIB
|
AUC0-24
a
|
−51.4 ± 10.9
|
4.9 ± 10.5
|
27.5 ± 8.6
|
67.4 ± 8.3
|
|
│Xb - PBO│c
|
0
|
56.3*
|
78.9***
|
118.8***
|
|
│Xb - PBO│/│PBO│, %
|
-
|
109.6
|
153.5
|
231.1
|
|
ADCS-ADL19
|
AUC0-24
a
|
−32.7 ± 6.4
|
−12.2 ± 6.2
|
−9.5 ± 5.0
|
1.4 ± 4.9
|
|
│Xb - PBO│c
|
0
|
20.5
|
23.3*
|
34.2***
|
|
│Xb - PBO│/│PBO│, %
|
-
|
62.6
|
71.1
|
104.4
|
|
NPId
|
AUC0-24
a
|
22.4 ± 12.2
|
−7.3 ± 11.8
|
−27.2 ± 9.7
|
−74.3 ± 9.4
|
|
│Xb - PBO│c
|
0
|
29.8
|
49.6**
|
96.8***
|
|
│Xb - PBO│/│PBO│, %
|
-
|
132.5
|
221.0
|
431.2
|
|
CIBIC-Plus
|
AUC0-24
a
|
6.0 ± 1.1
|
2.0 ± 1.0
|
1.4 ± 0.9
|
−2.1 ± 0.8
|
|
│Xb - PBO│c
|
0
|
4.0
|
4.6*
|
8.1***
|
|
│Xb - PBO│/│PBO│, %
|
-
|
65.9
|
76.2
|
135.6
|
|
4D-CI
|
AUC0-24
a
|
−175.4 ± 63.7
|
152.1 ± 61.5
|
344.7 ± 50.4
|
630.0 ± 49.0
|
|
│Xb - PBO│c
|
0
|
327.4**
|
520.0***
|
805.4***
|
|
│Xb - PBO│/│PBO│, %
|
-
|
186.7
|
296.6
|
459.3
|
-
aMean ± SE (point x week); bany active treatment group; cmean (point x week); dfor NPI, lower score indicates improvement. *P <0.05; **P <0.01; ***P <0.001. 4D-CI, four-dimensional composite index; ADCS-ADL19, 19-item Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale; AUC, area under the curve; CIBIC-Plus, Clinician’s Interview-Based Impression of Change – Plus Caregiver Input; MEM, memantine; MEM-DON, memantine added to background donepezil treatment; NPI, Neuropsychiatric Inventory; PBO, placebo; PBO-DON, placebo added to background donepezil treatment; SE, standard error of the mean; SIB, Severe Impairment Battery.
