[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505017":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":34,"responsibleParty":35,"collaborators":34,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":34,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":34,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":34,"overallStatus":58,"whyStopped":34,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":34},{"fullName":5,"class":6},"Shanghai 10th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ginkgo Ketone Ester Tablets Treatment Group","EXPERIMENTAL","Ginkgo Ketone Ester Tablets (Styron), taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic therapy continuously administered for 6 months",[13],"Drug: Ginkgo Ketone Ester Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","PLACEBO_COMPARATOR","placebo combined with conventional hypoglycemic therapy for 6 months",[19],"Drug: placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ginkgo Ketone Ester Tablets","Ginkgo Ketone Ester Tablets taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months",[9],[27],"Test group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"placebo","placebo, taken orally, 3 times a day, 0.5g each time, combined with conventional hypoglycemic treatment for six months",[15],[33],"Control group",null,{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Guoxiang Fu","Professor","100505017","phase-4-clinical-study-of-gkt-in-diabetes-related-dementia-100505017",false,"NCT05855863","Clinical Study of GKT in Diabetes Related Dementia","Clinical Study of Ginkgo Biloba Ketone Ester Tablets in Diabetes Related Dementia","Inclusion Criteria:\n\n1. Type 2 diabetes with mild cognitive impairment patients aged 65 years or above;\n2. Able to cooperate in completing cognitive function testing;\n3. Patients who can swallow pills\n4. No previous history of stroke，cerebral thrombosis, etc\n\nExclusion Criteria:\n\n1. Type 1 diabetes;\n2. Acute cerebral infarction and myocardial infarction within 3 months;\n3. Severe liver and kidney dysfunction;\n4. Late stage malignant tumors;\n5. Thyroid dysfunction；\n6. Brain injury and cerebral hemorrhage within 3 months；\n7. Folic acid and\u002For vitamin B12 deficiency\n8. Patients who are currently using thrombin inhibitors, defibrillators (with unclear efficacy in ischemic stroke and increased risk of bleeding), antiplatelet drugs, blood activating and stasis resolving agents, and other ginkgo biloba leaf preparations (as they may affect the evaluation of the therapeutic effect of ginkgo biloba ester tablets in this trial), as well as other trial medications.","ALL","60 Years","90 Years",{"count":50,"type":51},370,"ESTIMATED","INTERVENTIONAL",[54],"PHASE4","Recently a new clinical dementia subgroup based on brain imaging, called \"diabetes related dementia (DrD)\". DrD, unlike Alzheimer's disease and vascular dementia, is considered a \"controllable\" or \"modifiable\" form of dementia. However, there is currently a lack of corresponding treatment measures. Ginkgo biloba ketone ester tablets are extracts of Ginkgo biloba leaves. Previous studies have shown that they can increase cerebral blood flow, reduce cerebrovascular resistance, improve cerebral circulation, and are beneficial for the treatment of cognitive impairment. This project intends to explore the role of ginkgo ketoester tablets in diabetes related dementia through a multicenter randomized double-blind controlled clinical study.",[57],"Dementia","NOT_YET_RECRUITING","2023-11-09",{"date":61,"type":62},"2023-11-13","ACTUAL",{"date":64,"type":51},"2023-12-01",{"date":66,"type":51},"2026-06-30",{"name":5,"class":6}]