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

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