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This study will evaluate the pharmacological efficacy on language capability and compliance with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine on language capability in moderate to severe Alzheimer's disease patients who are taking stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in probable AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| donepezil maintain group | Other | continue already taking same dose (5mg or 10mg per day) of donepezil who assigned donepezil group |
|
| add-on Ebixa oral pump group | Active Comparator | Ebixa dosage titration (5mg per day for 1week, then 10mg per day for 1week, then 15mg per day for 1week, then up to 20mg per day) add-on already taking donepezil (5mg or 10mg per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebixa | Drug | add-on of Ebixa oral pump already receiving donepezil with stable dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| AQ-WAB(Western aphasia battery) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| ROSA (Relevant Outcome Scale for Alzheimer's Disease) | six months |
| Measure | Description | Time Frame |
|---|---|---|
| SIB-short form | six months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seol-Heui Han, PhD. MD | Contact | 82-2-2030-7561 | alzdoc@gw.kuh.ac | |
| Hyun Jeong Han, PhD. MD | Contact | 82-10-4489-8742 | neurohan@kd.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk university medical center | Recruiting | Seoul | 143-729 | South Korea |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| donepezil | Drug |
|
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |