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| Name | Class |
|---|---|
| Changchun Huayang High-tech Co., Ltd | INDUSTRY |
| Jiangsu Sheneryang High-tech Co., Ltd | UNKNOWN |
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Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octohydroaminoacridine Succinate Tablet | Experimental | Octohydroaminoacridine Succinate Tablet 4mg P.O. tid |
|
| Aricept | Active Comparator | Aricept 5mg/day P.O. |
|
| Placebo | Placebo Comparator | Placebo P.O. tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octohydroaminoacridine Succinate | Drug | Octohydroaminoacridine Succinate Tablet:4mg P.O. tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog) | The change of ADAS-Cog from baseline to endpoint among three arms. | 26 weeks double-blind study and 28 weeks extention study |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Interview Based Impression of Change - plus (CIBIC+) | The change of CIBIC+ from baseline to endpoint among three arms. | 26 weeks double-blind study and 28 weeks extention study |
| Activities of Daily Living (ADL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shifu Xiao, M.D., Ph.D. | Contact | +86 21 64387250 | 73441 | xiaoshifu@msn.com |
| Tao Wang, M.D., Ph.D. | Contact | +86 18017311279 | wtshhwy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shifu Xiao, M.D., Ph.D. | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
Other researchers should apply to the sponsor.
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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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| Aricept | Drug | Aricept 5mg/day, P.O. |
|
| Placebos | Drug | Placebo Tablet: P.O. tid |
|
The change of ADL from baseline to endpoint among three arms.
| 26 weeks double-blind study and 28 weeks extention study |
| Neuropsychiatric Inventory (NPI) | The change of NPI from baseline to endpoint among three arms. | 26 weeks double-blind study and 28 weeks extention study |
| 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 |