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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.