Table 1. Trials Evaluating Memantine for Alzheimer's Disease
| Trial | Sample Size | Study Population | Treatment | End Points | Results |
|---|---|---|---|---|---|
| Winblad
and colleagues (1999)11 |
151 | Patients with dementia secondary to AD or vascular dementiaMMSE <10GDS 5-7 | Memantine 10 mg daily for 12 weeks | CGI-C and care dependence as reported by the nursing staff | Positive response in CGI-C (p=0.001)Care dependence showed significant improvement with memantine (p=0.016) |
| Ruther and colleagues (2000)12 | 531 | Patients with advanced dementia secondary to AD, vascular dementia, or a "mixed" form of dementia GDS 5-7 | Memantine 15 mg daily for 6 weeks | CGI-C, and ADL-functioning as reported by caregiver via the D-Scale of Change (DS-C) | Memantine showed improvement in 87.3%, 73.1%, and 60% of patients in GDS stages 5, 6, and 7, respectively. In addition, improvements were noted in GDS stages 5, 6, and 7 in all items of the DS-C after 6 weeks (especially the "behaviour" and "ability to communicate" items). |
| Reisberg and colleagues (2003)6 | 252 | Patients with moderate-to-severe ADMMSE 3-14GDS 5-6 | Memantine 10 mg twice daily for 28 weeks | CIBIC-Plus, ADCS-ADLsev, SIB | CIBIC-Plus (p=0.03), ADCS-ADLsev (p=0.003), and SIB (p=0.001) all improved with memantine |
| Tariot and colleagues (2004)8 | 403 | Patients with moderate-to-severe AD, stable on donepezil therapy for the past 3 monthsMMSE 5-14 | Memantine 10 mg twice daily plus donepezil for 24 weeks | Primary:ADCS-ADL, SIB | CIBIC-Plus (p=0.027), ADCS-ADL (p=0.028), and SIB (p=0.001) all improved with memantine/donepezil therapy |
ADCS-ADLsev = Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory
ADL = Activities of Daily Living
CGI-C = Clinical Global Impression of
Change
CIBIC-Plus = Clinician's Interview-Based Impression of Change Plus
Caregiver Input
SIB = Severe Impairment Battery
NPI = Neuropsychiatric
Inventory, BGP = Behavioral Rating Scale for Geriatric Patients