The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary objective is to compare the efficacy and safety between rivastigmine patch monotherapy and combination therapy with memantine in patients with AD. The study hypothesis is that the tolerability of the combination therapy with memantine is not inferior to that of rivastigmine patch monotherapy in AD patients.
Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. We hypothesized that combination of memantine and rivastigmine patch will be safe and well tolerated and result in more clinical benefit in patients with AD in comparison with rivastigmine patch monotherapy, for the mechanisms of the drugs are different.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.
All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.
Soonchunhyang University Hospital
Bucheon-si, South Korea
Retention rate at week 16 after randomization
Time frame: End point (16 weeks after randomization)
Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Mini-Mental State Examination
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Frontal Assessment Battery
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Time frame: 16 weeks after randomization
Safety
Time frame: from baseline to end-point
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