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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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The main purpose of this study is to evaluate the safety and efficacy of Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to moderate Alzheimer's Disease.
The purpose of this study is a preliminary assessment of the Octohydroaminoacridine Succinate tablets in the treatment of mild to moderate Alzheimer's disease and explore the efficacy and safety of the best dose. The 288 patients were randomly assigned to four groups: high dose (4mg / time), moderate dose (2mg / time), low dose (1mg / time) and the placebo group, including four weeks of the trial screening period following 16 weeks double-blind treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose | Experimental | 1mg, tid |
|
| Moderate dose | Experimental | 2mg,tid |
|
| High dose | Experimental | 4mg,tid |
|
| Placebo | Placebo Comparator | 0 mg, tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octohydroaminoacridine Succinate Tablets | Drug | 1mg, tid |
| |
| Octohydroaminoacridine Succinate Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale | 20weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician's Interview Based Impression of Change, plus caregiver input | 20weeks | |
| Activities of Daily Living:Activities of Daily Living Scale(ADL) | 20weeks | |
| Mental behavior: neuropsychiatric questionnaire (NPI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang Li, MD | Contact | 86-21-64387250 | 3128 | lhlh5@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shifu Xiao, MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Brain Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Drug |
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid |
|
| Octohydroaminoacridine succinate Tablets | Drug | 1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid |
|
| Placebo | Drug | 0mg, tid |
|
| 20weeks |
| Affiliated Hospital of Guilin Medical University | Recruiting | Guilin | Guangxi | China |
|
| Hebei mental health center | Recruiting | Baoding | Hebei | China |
|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
|
| The first Affiliated Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
|
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
|
| The First Affiliated Hospital of Medical School of Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
|
| Beijing HuiLongGuan Hospital | Recruiting | Beijing | China |
|
| Beijing Shijitan Hospital, EMU | Recruiting | Beijing | China |
|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | China |
|
| Shanghai First People's Hospital | Recruiting | Shanghai | China |
|
| Shanghai Tenth People's hospital | Recruiting | Shanghai | China |
|
| Shanghai | Recruiting | Shanghai | China |
|
| 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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