Table 2.
Summary of the major randomized controlled trials involving addition of memantine to patients with AD already on a stable dose of cholinesterase inhibitor
| Study | MEM-MD-0234 | MEM-MD-1235 | MEM-MD-5021 | DOMINO-AD39 |
|---|---|---|---|---|
| Treatment | Memantine IR (20 mg/day) vs placebo | Memantine IR (20 mg/day) vs placebo | Memantine ER 28 mg once daily vs placebo | Memantine IR (20 mg/day) vs placebo when donepezil was continued |
| Population | 404 participants with moderate-to-severe AD (mean MMSE 10.1) on stable dose of donepezil | 433 participants with mild-to-moderate AD (mean MMSE 16.8) on stable dose of ChEI | 677 participants with moderate-to-severe AD (mean MMSE 10.8) on stable dose of ChEI | 295 participants with moderate-to-severe AD (mean MMSE 9.0) on stable dose of donepezil |
| Duration | 24 weeks | 24 weeks | 24 weeks | 52 weeks |
| Cognitive scale | Significantly favored memantine IR on SIBa | No significant difference on ADAS-Coga | Significantly favored memantine ER on SIBa | No significant difference on sMMSEa |
| Global rating scale | Significantly favored memantine IR on CIBIC-plus | No significant difference on CIBIC-plusa | Significantly favored memantine ER on CIBIC-plusa | |
| Functional scale | Significantly favored memantine IR on ADCS-ADL-19a | No significant difference on ADCS-ADL-23 | No significant difference on ADCS-ADL-19 | No significant difference on BADLSa |
| Behavioral scale | Significantly favored memantine IR on NPI | No significant difference on NPI | Significantly favored memantine ER on NPI | Significantly favored memantine IR on NPI |
Note:
Indicates primary efficacy endpoints.
Abbreviations: AD, Alzheimer’s disease; ADCS-ADL-19, 19-item Alzheimer Disease Cooperative Study-Activities of Daily Living Inventory; ADCS-ADL-23, 23-item Alzheimer Disease Cooperative Study-Activities of Daily Living Inventory; BADLS, Bristol Activities of Daily Living Scale; ChEI, cholinesterase inhibitor; CIBIC-plus, Clinician’s Interview-Based Impression of Change Plus Caregiver Input; ER, extended-release; IR, immediate-release; NPI, Neuropsychiatric Inventory; SIB, Severe Impairment Battery; sMMSE, Standardized Mini-Mental State Examination.