Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-13 @ 5:28 AM
Study NCT ID:
NCT01453569
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2011-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'xinxianliang@hotmail.com', 'phone': '86 21-50504988', 'title': 'Dr. Xianliang Xin', 'phoneExt': '1370', 'organization': 'Shanghai Greenvalley Pharmaceutical Co., Ltd.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks', 'otherNumAtRisk': 86, 'otherNumAffected': 3, 'seriousNumAtRisk': 86, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks', 'otherNumAtRisk': 84, 'otherNumAffected': 12, 'seriousNumAtRisk': 84, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule', 'otherNumAtRisk': 85, 'otherNumAffected': 5, 'seriousNumAtRisk': 85, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Ear and labyrinth', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Gastrointestinal', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Injuries, toxicosis, complications due to surgery', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Muscular and connective tissue', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'CNS disorders', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Psychiatiric disorders', 'notes': 'Medication-related AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Reproductive 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Behavioral and psychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Implantation of artificial heart pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Paralysis of oculomotor nerve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Emptying disorder of intestine and stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chill', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Compressive fracture of vertebra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.58', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '0.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': "Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.'}, {'type': 'SECONDARY', 'title': "Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}], 'classes': [{'title': 'Markedly improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderately improved', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Moderately worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Markedly worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '0.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': "Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.'}, {'type': 'SECONDARY', 'title': 'Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'OG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-2.08', 'spread': '0.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'FG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Oligo-mannurarate 900mg', 'description': 'Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks'}, {'id': 'BG001', 'title': 'Sodium Oligo-mannurarate 600mg', 'description': 'Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: simulant of sodium oligo-mannurarate capsule'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.39', 'spread': '8.51', 'groupId': 'BG000'}, {'value': '70.26', 'spread': '8.40', 'groupId': 'BG001'}, {'value': '70.34', 'spread': '8.13', 'groupId': 'BG002'}, {'value': '70.33', 'spread': '8.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All the treated subjects were evaluated for safety. 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-25', 'studyFirstSubmitDate': '2011-09-30', 'resultsFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-25', 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'timeFrame': '24 weeks', 'description': "Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement."}], 'secondaryOutcomes': [{'measure': "Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'timeFrame': '24 weeks', 'description': "Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse."}, {'measure': "Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule", 'timeFrame': '24 weeks', 'description': "Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement."}, {'measure': 'Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule', 'timeFrame': '24 weeks', 'description': 'Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '32928279', 'type': 'DERIVED', 'citation': "Wang T, Kuang W, Chen W, Xu W, Zhang L, Li Y, Li H, Peng Y, Chen Y, Wang B, Xiao J, Li H, Yan C, Du Y, Tang M, He Z, Chen H, Li W, Lin H, Shi S, Bi J, Zhou H, Cheng Y, Gao X, Guan Y, Huang Q, Chen K, Xin X, Ding J, Geng M, Xiao S. A phase II randomized trial of sodium oligomannate in Alzheimer's dementia. Alzheimers Res Ther. 2020 Sep 14;12(1):110. doi: 10.1186/s13195-020-00678-3."}]}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.", 'detailedDescription': "Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least primarily educated.\n* Accord with Probable Alzheimer disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)'s Criteria.\n* 10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.\n* Hachinski ischemia scale \\<4 points.\n* Hamilton depression scale ≤10 points.\n* Should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. The accompanying person should help the patient throughout the trial.\n* Signed the information consent form.\n\nExclusion Criteria:\n\n* Have been in other clinical trials within 30 days before this trial' start.\n* women during pregnancy or lactation.\n* Dementia caused by other diseases.\n* previous nervous system diseases.\n* Abnormal laboratory results.\n* Uncontrolled hypertension.\n* Unstable or serious diseases of heart, lung, liver, kidney and blood.\n* Visual or auditory handicap.\n* Significant focal lesions revealed by electronic computer X-ray tomography(CT) or magnetic resonance imaging(MRI) in one year before enrollment.\n* Alcohol abuse or drug abuse.\n* psychotic, including patients with serious depression.\n* Patients being in drug therapy of Alzheimer disease which cannot be stopped.\n* In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the recruitment.\n* Investigator consider the patient cannot finish this trial for any reason.\n* Relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor."}, 'identificationModule': {'nctId': 'NCT01453569', 'briefTitle': "Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Greenvalley Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease', 'orgStudyIdInfo': {'id': '9712011-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sodium oligo-mannurarate 900mg', 'interventionNames': ['Drug: Sodium oligo-mannurarate 900mg']}, {'type': 'EXPERIMENTAL', 'label': 'sodium oligo-mannurarate 600mg', 'interventionNames': ['Drug: Sodium oligo-mannurarate 600mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sodium 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