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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rivastigmine patch monotherapy | Active Comparator |
| |
| Combination therapy with memantine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine transdermal patch (Exelon patch), memantine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate at week 16 after randomization | End point (16 weeks after randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale | 16 weeks after randomization | |
| Change from baseline at week 16 in Mini-Mental State Examination | 16 weeks after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong Choi, MD | Department of Neurology, Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital | Bucheon-si | 420-767 | South Korea | |||
| The Catholic University of Korea Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21561398 | Derived | Choi SH, Park KW, Na DL, Han HJ, Kim EJ, Shim YS, Lee JH; Expect Study Group. Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer's disease: a multicenter, randomized, open-label, parallel-group study. Curr Med Res Opin. 2011 Jul;27(7):1375-83. doi: 10.1185/03007995.2011.582484. Epub 2011 May 12. |
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|
|
| Rivastigmine transdermal patch | Drug | 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. |
|
|
| Change from baseline at week 16 in Frontal Assessment Battery | 16 weeks after randomization |
| Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living | 16 weeks after randomization |
| Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory | 16 weeks after randomization |
| Change from baseline at week 16 in Cohen Mansfield Agitation Inventory | 16 weeks after randomization |
| Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes | 16 weeks after randomization |
| Safety | from baseline to end-point |
| Bucheon-si |
| South Korea |
| Donga University Hospital | Busan | 602-715 | South Korea |
| Changwon Fatima Hospital | Changwon | 641-560 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea |
| Daejun Eulji University Hopistal | Daejun | 302-799 | South Korea |
| Dongguk University Medical Center | Goyang | 41-773 | South Korea |
| Myongji Hospital | Goyang | 412-270 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Wonkwang University Hospital | Iksan | 570-180 | South Korea |
| Inha Univeristy Hospital | Incheon | 400-711 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Pusan National University Hospital | Pusan | 602-739 | South Korea |
| Maryknoll Hospital | Pusan | South Korea |
| Bobath Memorial Hospital | Seongnam | South Korea |
| Kyughee University Medical Center | Seoul | 130-702 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 134-701 | South Korea |
| Sungkyunkwan University, Samsung Seoul Hospital | Seoul | 135-710 | South Korea |
| Konkuk University Hospital | Seoul | 143-729 | South Korea |
| Hallym University Hospital | Seoul | 150-719 | South Korea |
| Ewha Womans University Hospital | Seoul | 158-710 | South Korea |
| Asan Medical Center | Seoul | 431-060 | South Korea |
| Seoul Eulji Hospital | Seoul | South Korea |
| Seoul Medical Center | Seoul | South Korea |
| Seoul National University Boramae Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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