Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 10:02 PM
Study NCT ID:
NCT04520412
Status:
SUSPENDED
Last Update Posted:
2022-11-23
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2046}}, 'statusModule': {'whyStopped': 'The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate the population PK', 'timeFrame': 'Baseline, 12 Weeks, 24 Weeks, 52 Weeks', 'description': 'Determine serum levels of GV-971 in population PK'}, {'measure': 'Evaluate the effect of GV-971 on brain structure neurodegeneration', 'timeFrame': 'Baseline, 52 Weeks', 'description': 'Changes from baseline in volumetric magnetic resonance imaging (MRI)'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the ADAS-cog/11 score', 'timeFrame': 'Baseline, 48 weeks and 52 weeks', 'description': "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."}, {'measure': 'Change from baseline in the ADCS-CGIC score', 'timeFrame': 'Baseline, 48 weeks and 52 weeks', 'description': "Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome."}], 'secondaryOutcomes': [{'measure': 'Change from baseline in NPI score', 'timeFrame': 'Baseline, 36 Weeks, 52 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 MMSE score', 'timeFrame': 'Baseline, 52 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 ADCS-ADL23 score', 'timeFrame': 'Baseline, 36 Weeks, 52 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."}, {'measure': 'Change from baseline in NPI caregiver items', 'timeFrame': 'Baseline, 52 Weeks', 'description': 'Change from baseline in Neuropsychiatric Inventory (NPI) caregiver items . The total score of NPI caregiver items is 0-60, with higher scores mean a worse outcome.'}, {'measure': 'Change from baseline in ZBI score', 'timeFrame': 'Baseline, 52 Weeks', 'description': 'Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome.'}, {'measure': 'Assess the efficacy of GV-971 throughout the OLE period', 'timeFrame': 'Baseline, 52 Weeks, 78 Weeks', 'description': "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."}, {'measure': 'Assess the efficacy of GV-971 throughout the OLE period', 'timeFrame': 'Baseline, 52 Weeks, 78 Weeks', 'description': "Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. 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MRI.\n* A resting heart rate of \\< 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position.\n* Major medical illness or unstable medical condition within 6 months of screening.\n* Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.\n* Inadequate hepatic function.\n* Inadequate organ and marrow function.\n* ECG clinically significant abnormalities.'}, 'identificationModule': {'nctId': 'NCT04520412', 'acronym': 'GREEN MEMORY', 'briefTitle': "A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Green Valley (Shanghai) Pharmaceuticals Co., Ltd.'}, 'officialTitle': "A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 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