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The purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia.
Probable Alzheimer type dementia compare INM-176 1200~1600mg/day with Donepezil 5~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aricept | Active Comparator | Intervention: Drug: Aricept |
|
| INM-176 | Experimental | Intervention: Drug: INM-176 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aricept | Drug | Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Mini-Mental State Examination (MMSE) | up to 24 weeks | |
| Change from baseline to endpoint in Clinical Dementia Rating | up to 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SangYoon Kim, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whanin Pharm.Co.,Ltd. | Seoul | Moonjung | 138-200 | 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 |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| INM-176 | Drug | INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks |
|
|
| Change from baseline to endpoint in Global Deterioration Scale(GDS) |
| up to 24 weeks |
| Change from baseline to endpoint in Korean Activity of Living(K-IADL) | up to 24 weeks |
| Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) | up to 24 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |