Parameter | MRZ-90001-9605 [ 6 ] | MEM-MD-01 [ 8 ] | MEM-MD-02 [ 7 ] | MEM-MD-50 [ 5 ] | ||||
---|---|---|---|---|---|---|---|---|
MEM monotherapy | MEM monotherapy | MEM added to DON | MEM added to ChEI | |||||
10 mg b.i.d. IR | 10 mg b.i.d. IR | 10 mg b.i.d. IR | 28 mg q.d. ER | |||||
PBO | MEM | PBO | MEM | PBO/DON | MEM/DON | PBO/ChEI | MEM/ChEI | |
(number = 126) | (number = 126) | (number = 172) | (number = 178) | (number = 201) | (number = 202) | (number = 335) | (number = 341) | |
Baseline patient characteristics | ||||||||
Age, yearsa | 76.3 ± 7.8 | 75.9 ± 8.4 | 78.3 ± 7.6 | 78.1 ± 8.2 | 75.5 ± 8.7 | 75.5 ± 8.4 | 76.8 ± 7.8 | 76.2 ± 8.4 |
Women, number (%) | 79 (63) | 91 (72) | 121 (70) | 129 (72) | 134 (67) | 128 (63) | 243 (72) | 244 (72) |
White, number (%) | 115 (91) | 112 (89) | 141 (82) | 142 (80) | 186 (92) | 182 (90) | 312 (93) | 324 (95) |
Weight, kga | 66.1 ± 14.1 | 64.5 ± 12.4 | 65.9 ± 12.8 | 64.5 ± 13.5 | 66.2 ± 14.1 | 70.5 ± 14.3 | 64.6 ± 13.3 | 65.1 ± 12.8 |
MMSE scorea | 8.1 ± 3.6 | 7.7 ± 3.7 | 10.3 ± 3.1 | 10.0 ± 2.8 | 10.2 ± 3.0 | 9.9 ± 3.1 | 10.6 ± 2.9 | 10.9 ± 2.9 |
MMSE rangeb | 1 to 14 | 5 to 16 | 5 to 16 | 3 to 17 | ||||
Concomitant anti-dementia treatment | none | none | donepezil | ChEI | ||||
PBO/DON: number = 217 | ||||||||
MEM/DON: number = 219 | ||||||||
Duration, weeks | 28 | 24 | 24 | 24 | ||||
Score changes from baseline at study endpoint (LOCF)a | ||||||||
SIB (number) | −9.8 ± 13.4 (126) | −3.9 ± 11.3 (126) | −2.6 ± 8.6 (165) | −1.7 ± 11.4 (170) | −2.3 ± 9.0 (196) | 1.0 ± 7.9 (198) | 0.3 ± 11.5 (327) | 2. ± 11.2 (332) |
P valuec | <0.001 | 0.62 | <0.001 | 0.001 | ||||
ADCS-ADL19 (number) | −5.1 ± 6.3 (126) | −3.0 ± 6.8 (126) | −2.1 ± 5.5 (165) | −1.5 ± 6.8 (171) | −3.2 ± 6.0 (197) | −1.8 ± 6.5 (198) | −1.3 ± 7.7 (328) | −0.7 ± 6.9 (331) |
P valuec | 0.022 | 0.28 | 0.028 | 0.18 | ||||
NPI (number) | 3.6 ± 15.6 (126) | 0.4 ± 15.4 (126) | −0.2 ± 14.5 (154) | −1.0 ± 15.9 (161) | 3.6 ± 14.0 (189) | −0.2 ± 11.2 (193) | −1.6 ± 12.7 (321) | −4.3. ± 14.6 (318) |
P valuec | 0.37 | 0.96 | 0.002 | 0.005 | ||||
CIBIC-Plusd (number) | 4.7 ± 1.1 (126) | 4.5 ± 1.1 (126) | 4.6 ± 1.0 (163) | 4.3 ± 1.0 (171) | 4.7 ± 1.0 (196) | 4.4 ± 1.0 (198) | 4.1 ± 1.2 (328) | 3.8 ± 1.2 (333) |
P valuee | 0.06 | 0.18 | 0.027 | 0.008 |