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Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Oligomannate Capsules (GV-971) | Experimental | The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oligomannate Capsules (GV-971) | Drug | Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the ADAS-cog/11 score | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. | Baseline, 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ADAS-Cog/11 score | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome. | Baseline, 96 weeks |
| Change from baseline in MMSE score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | China | |||
| Peking University Shougang Hospital |
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Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome. |
| Baseline, 48 weeks, 96 weeks |
| Change from baseline in ADCS-ADL score | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. | Baseline, 48 weeks, 96 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971. | 48 weeks, 96 weeks |
| Beijing |
| Beijing Municipality |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | China |
| The First People's Hospital of Foshan | Foshan | Guangdong | China |
| Nanfang Hospital | Guangzhou | Guangdong | China |
| The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| No.6 HeBei Provincial People's Hospital | Baoding | Hebei | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China |
| The First Hospital of Changsha | Changsha | Hunan | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | China |
| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | China |
| The Second Hospital of Shandong University | Jinan | Shandong | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
| Shanghai 6th People's Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | China |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | China |
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Tongde Hospital of Zhejiang Province | Hangzhou | Zhejiang | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 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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| ID | Term |
|---|---|
| C000710388 | GV-971 |
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