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The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GV-971 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GV-971 | Drug | Administered PO |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the ADAS-cog/12 score | Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome. | Baseline, 36 weeks |
| Change from baseline in ADCS-ADL23 score | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. | Baseline, 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MMSE score | 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, 36 weeks |
| Change from baseline in the CIBIC-Plus score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on A-beta protein of CSF | Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment. | Baseline, 36 weeks |
| Change from baseline on Tau protein of CSF | Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Ph. D | Contact | +86 21 50504988 | 8821 | xinxianliang@greenvalleypharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huainan First People's Hospital | Recruiting | Huainan | Anhui | China |
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| Drug |
Administered PO |
|
Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
| Baseline, 36 weeks |
| Change from baseline in NPI score | Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome. | Baseline, 36 weeks |
| Change from baseline in ADCS-ADL23 score | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. | Baseline, 36 weeks |
| Baseline, 36 weeks |
| Change from baseline on biomarkers of Th1/Th2 cell subtypes | Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment. | Baseline, 36 weeks |
| Beijing Anding Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Anzhen Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Tongren Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University Shougang Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The First Medical Center, Chinese PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hopsital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Guangdong Provincial Hospital of Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Affiliated Brain Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hopsital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Second Affiliated Hopsital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| Peking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
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| The First People's Hospital of Nanning | Recruiting | Nanning | Guangxi | China |
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| Shijiazhuang People's Hospital | Recruiting | Shijiazhuang | Hebei | China |
|
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| The Second Hopsital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| Tangshan Workers' Hospital | Recruiting | Tangshan | Hebei | China |
|
| The First Affiliated Hopsital of Nanyang Medical College | Not yet recruiting | Nanyang | Henan | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) | Not yet recruiting | Wuhan | Hubei | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Chenzhou First People's Hospital | Not yet recruiting | Chenzhou | Hunan | China |
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| Yueyang Central Hospital | Not yet recruiting | Yueyang | Hunan | China |
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| Huai'an Second People's Hospital | Not yet recruiting | Huai'an | Jiangsu | China |
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| Nanjing Brain Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Affiliated Hospital of Nantong University | Not yet recruiting | Nantong | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Yangzhou First People's Hospital | Not yet recruiting | Yangzhou | Jiangsu | China |
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| Jiujiang University Affiliated Hospital | Recruiting | Jiujiang | Jiangxi | China |
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| The Second Affiliated Hopsital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| Inner Mongolia International Hospital of Mongolian Medicine | Not yet recruiting | Hohhot | Neimenggu | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | China |
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| Shandong Provincial Hospital | Not yet recruiting | Jinan | Shandong | China |
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| Qilu Hospital of Shandong University (Qingdao) | Not yet recruiting | Qingdao | Shandong | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | China |
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| Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Xianyang Hospital of Yan'an University | Not yet recruiting | Xianyang | Shanxi | China |
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| The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital of Air Force Medical University) | Not yet recruiting | Xi’an | Shanxi | China |
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| Xi'an Mental Health Center | Not yet recruiting | Xi’an | Shanxi | China |
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| Hospital of Chengdu University of TCM | Not yet recruiting | Chengdu | Sichuan | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| The Affiliated Hopsital of Inner Mongolia Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The Second Hospital of Jiaxing | Recruiting | Jiaxing | 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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