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The primary purpose of this study is to determine the efficacy and safety of Sodium Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium oligo-mannurarate 900mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium oligo-mannurarate 900mg | Drug | sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) of sodium oligo-mannurarate capsule | 36 weeks | |
| Improvement of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) of sodium oligo-mannurarate capsule | 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Beijing | Beijing Municipality | 100005 | China | ||
| Chongqing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33475022 | Derived | Ferrari C, Sorbi S. The complexity of Alzheimer's disease: an evolving puzzle. Physiol Rev. 2021 Jul 1;101(3):1047-1081. doi: 10.1152/physrev.00015.2020. Epub 2021 Jan 21. |
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| Placebo | Drug | simulant of sodium oligo-mannurarate capsule |
|
| Improvement of Neuropsychiatric Inventory(NPI) of sodium oligo-mannurarate capsule | 36 weeks |
| Glucose metabolism of bilateral temporoparietal cortex | Obtained by Positron Emission Tomography in two sites. | 36 weeks |
| Chongqing |
| Chongqing Municipality |
| 400010 |
| China |
| Fujian | Fuzhou | Fujian | China |
| Guangzhou | Guangzhou | Guangdong | China |
| Wuhan | Wuhan | Hubei | 430077 | China |
| Changsha | Changsha | Hunan | China |
| Nanjing | Nanjing | Jiangsu | China |
| Suzhou | Suzhou | Jiangsu | China |
| Yangzhou | Yangzhou | Jiangsu | China |
| Jinan | Jinan | Shandong | 250021 | China |
| Shanghai | Shanghai | Shanghai Municipality | 200030 | China |
| Xi'an | Xi’an | Shanxi | China |
| Sichuan | Chengdu | Sichuan | 610041 | China |
| Tianjin | Tianjin | Tianjin Municipality | 300052 | China |
| Hangzhou | Hangzhou | Zhejiang | 310016 | China |
| Wenzhou | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000710388 | GV-971 |
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