Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-26 @ 8:20 AM
Study NCT ID:
NCT05908695
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710388', 'term': 'GV-971'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline on A-beta protein of CSF', 'timeFrame': 'Baseline, 36 weeks', 'description': 'Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment.'}, {'measure': 'Change from baseline on Tau protein of CSF', 'timeFrame': 'Baseline, 36 weeks', 'description': 'Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment.'}, {'measure': 'Change from baseline on biomarkers of Th1/Th2 cell subtypes', 'timeFrame': 'Baseline, 36 weeks', 'description': 'Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the ADAS-cog/12 score', 'timeFrame': 'Baseline, 36 weeks', 'description': "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."}, {'measure': 'Change from baseline in ADCS-ADL23 score', 'timeFrame': 'Baseline, 36 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change from baseline in MMSE score', 'timeFrame': 'Baseline, 36 weeks', 'description': '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.'}, {'measure': 'Change from baseline in the CIBIC-Plus score', 'timeFrame': 'Baseline, 36 weeks', 'description': "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."}, {'measure': 'Change from baseline in NPI score', 'timeFrame': 'Baseline, 36 weeks', 'description': 'Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.'}, {'measure': 'Change from baseline in ADCS-ADL23 score', 'timeFrame': 'Baseline, 36 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate AD per NIA-AA.\n* History of cognitive and functional decline over at least 1 year.\n* MMSE scores between 11 and 24 (inclusive) at baseline.\n* Hachinski Ischemic Score (HIS) scale total score ≤ 4.\n* Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.\n* Brain MRI scan show the highest possibility of AD.\n* Have a reliable study partner/caregiver.\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis of a dementia-related central nervous system disease other than AD.\n* Major structural brain disease as judged by MRI.\n* A resting heart rate of \\< 50 beats per minute (bpm) after 10 minutes of rest.\n* Major medical illness or unstable medical condition within 12 months of screening.\n* Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.\n* Inadequate hepatic function.\n* Inadequate organ function.\n* ECG clinically significant abnormalities.'}, 'identificationModule': {'nctId': 'NCT05908695', 'briefTitle': "An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Green Valley (Shanghai) Pharmaceuticals Co., Ltd.'}, 'officialTitle': "A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'GV-971-PoCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GV-971', 'interventionNames': ['Drug: GV-971']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GV-971', 'type': 'DRUG', 'description': 'Administered PO', 'armGroupLabels': ['GV-971']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered PO', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huainan', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Zhang', 'role': 'CONTACT'}, {'name': 'Chuanqing Yu', 'role': 'CONTACT'}], 'facility': "Huainan First People's Hospital", 'geoPoint': {'lat': 32.62639, 'lon': 116.99694}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinge Zhang', 'role': 'CONTACT'}], 'facility': 'Beijing Anding Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangzhi Liu', 'role': 'CONTACT'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haibo Chen', 'role': 'CONTACT'}], 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': 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'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kunmu Zheng', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hopsital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yefeng Cai', 'role': 'CONTACT'}], 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuping Ning', 'role': 'CONTACT'}], 'facility': 'The Affiliated Brain Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Liu', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hopsital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Liu', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hopsital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuhui Chen', 'role': 'CONTACT'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianfeng Li', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Nanning", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huiying Zhao', 'role': 'CONTACT'}], 'facility': 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First Affiliated Hopsital of Nanyang Medical College', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiewen Zhang', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Shao', 'role': 'CONTACT'}], 'facility': 'Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deren Hou', 'role': 'CONTACT'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 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Inner Mongolia Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiufeng Xu', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Peng', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jiaxing', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanping Wang', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Jiaxing', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}], 'centralContacts': [{'name': 'Medical Director, Ph. D', 'role': 'CONTACT', 'email': 'xinxianliang@greenvalleypharma.com', 'phone': '+86 21 50504988', 'phoneExt': '8821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Valley (Shanghai) Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}