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The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline alfoscerate | Experimental | Drug: Choline alfoscerate and Donepezil concomitant administration |
|
| Placebo | Placebo Comparator | Drug: Donepezil only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline alfoscerate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| change of ADAS-cog score compared with Baseline | Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jina Song | Contact | 82-2-550-8865 | jnsong058@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Sungnam | South Korea |
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|
| 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 |
|---|---|
| D005997 | Glycerylphosphorylcholine |
| ID | Term |
|---|---|
| D005994 | Glycerophosphates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D054709 | Lecithins |
| D010713 | Phosphatidylcholines |
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