Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02982603
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2016-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526713', 'term': 'ginaton'}, {'id': 'C063170', 'term': 'Ginkgo biloba extract'}]}}, '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': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to end of double-blind treatment of Alzheimer Disease Assessment Scale-cognitive subscale', 'timeFrame': 'week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.'}, {'measure': 'Change from baseline to end of double-blind treatment of rate of conversion to dementia', 'timeFrame': 'week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State Examination(MMSE)', 'timeFrame': 'week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.'}, {'measure': 'Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)', 'timeFrame': 'week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.'}, {'measure': "Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24)", 'timeFrame': 'week 0, week 4, week 12, week 24 ,week 36 , week 48 and week 52.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Herbal Medicine Allergy']}, 'descriptionModule': {'briefSummary': "This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase VI trial being carried out in 20 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2 times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton) (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. cognitive complaints from the patients or their families;\n2. objective evidence for memory impairment, delayed story recall test(DSR)\\<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);\n3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);\n4. preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;\n5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;\n6. absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria,\n7. enough vision and hearing to accomplishment neuropsychological test;\n8. capability to read words and write simple sentence;\n9. capability and willingness to give informed consent and to comply with the study procedures.\n\nExclusion Criteria:\n\n1. non amnestic Mild cognitive impairment;\n2. meeting the diagnostic criteria for dementia;\n3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse\n4. having significant psychiatric disease, depression, the Hamilton depression scale \\>12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)\\>4;\n5. combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;\n6. used cholinesterase inhibitors or memantine within 1 month;\n7. history of hypersensitivity to the treatment drugs;\n8. concomitant drugs with the potential to interfere with cognition;\n9. administration of other investigational drugs; severe impairment of the functions of the kidney or liver;\n10. vegetarians or contraindications for animal innards."}, 'identificationModule': {'nctId': 'NCT02982603', 'briefTitle': 'Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'The Efficacy and Safety of Qinggongshoutao Bolus for aMnestic Mild Cognitive Impairment: A 52- Week Randomized, Double-blind, Controlled,Three Arms, Multi-center Study', 'orgStudyIdInfo': {'id': 'Z12020286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qinggongshoutao Bolus', 'description': 'Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761 .Qinggongshoutao bolus 70 pills every time (7g), 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.', 'interventionNames': ['Drug: Qinggongshoutao Bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ginkgo Biloba Extract 761', 'description': 'Ginkgo Biloba Extract 761 and placebo identified to Qinggongshoutao bolus.The subjects will take Ginkgo Biloba Extract 761 2 times per day, 2 pills per time(80mg) ,and identified to Qinggongshoutao bolus 70 pills every time, 2 times per day for 48 weeks.', 'interventionNames': ['Drug: Ginkgo Biloba Extract 761']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': 'Placebo identified to Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761.Placebo identified to Qinggongshoutao bolus 70 pills every time, 2 times per day and placebo identified to Ginkgo Biloba Extract 761, 2 pills per time, 2 times per day for 48 weeks.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Qinggongshoutao Bolus', 'type': 'DRUG', 'otherNames': ['Ginkgo biloba also named Egb761 or Ginaton'], 'description': 'Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761', 'armGroupLabels': ['Qinggongshoutao Bolus']}, {'name': 'Ginkgo Biloba Extract 761', 'type': 'DRUG', 'otherNames': ['Ginkgo biloba also named Egb761 or Ginaton'], 'description': 'Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761', 'armGroupLabels': ['Ginkgo Biloba Extract 761']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba', 'armGroupLabels': ['Placebos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Dongzhimen Hospital ,Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jinzhou Tian, M.D,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongzhimen Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jinzhou Tian', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}