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Table 1 Summary of patient characteristics and clinical outcomes in memantine trials in moderate to severe AD

From: Cumulative, additive benefits of memantine-donepezil combination over component monotherapies in moderate to severe Alzheimer’s dementia: a pooled area under the curve analysis

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  
  1. aMean ± SD; bMMSE range shown is actual, which may differ from protocol-specified range; c P values for continuous variables (ADCS-ADL19, SIB, NPI) were generated using ANCOVA models for all trials except for MRZ-90001-9605, in which the Wilcoxon-Mann–Whitney test was used. For the categorical variable (CIBIC-Plus), P values were generated using a Cochran-Mantel-Haenszel test, except for the MRZ-90001-9605 trial, in which Wilcoxon-Mann–Whitney test was used; dCIBIC-Plus rating reflects a change from baseline; therefore, endpoint values are used; e P values for CIBIC-Plus are based on the CMH test. AD, Alzheimer’s disease; ADCS-ADL19, 19-item Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale; ANCOVA, analysis of covariance; b.i.d., twice daily; ChEI, cholinesterase inhibitor; CIBIC-Plus, Clinician’s Interview-Based Impression of Change – Plus Caregiver Input scale; DON, donepezil; ER, extended release; IR, immediate release; MEM, memantine; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory; OC, observed cases; PBO, placebo; q.d., once daily; SD, standard deviation; SIB, Severe Impairment Battery.