[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599335":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":160,"collaborators":163,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":32,"eligibilityCriteria":183,"healthyVolunteers":179,"sex":184,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":32,"studyType":190,"phases":191,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":68,"whyStopped":32,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mazdutide group","EXPERIMENTAL","Participants will receive weekly subcutaneous injections of mazdutide (starting at 2.0 mg, with stepwise dose escalation to a target maintenance dose of 4.0 mg and optional adaptive increase to 6.0 mg if necessary and tolerated) , in addition to their existing glucose-lowering therapy.",[13],"Drug: Mazdutide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Participants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Mazdutide","Mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.",[9],[27],"IBI362",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Yan Bi, MD, PhD","Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","6-25-83-105302.","biyan@nju.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Zhou Zhang, MD, PhD","86-25-83-105302","zhangzhou@smail.nju.edu.cn",[48,66,83,100,111,120,133,148],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Endocrinology, Xiangya Hospital of Central South University","NOT_YET_RECRUITING","Changsha","Hunan","410008","China","CN",{"type":57,"coordinates":58},"Point",[59,60],112.97087,28.19874,{"lat":60,"lon":59},[63,65],{"name":64,"role":40,"phone":32,"phoneExt":32,"email":32},"Jing Wu, MD, PhD",{"name":64,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":67,"status":68,"city":69,"state":70,"zip":32,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Department of Endocrinology, Changzhou No.2 People's Hospital","RECRUITING","Changzhou","Jiangsu",{"type":57,"coordinates":72},[73,74],119.95401,31.77359,{"lat":74,"lon":73},[77,79,81],{"name":78,"role":40,"phone":32,"phoneExt":32,"email":32},"Huijie Yang, MD",{"name":80,"role":37,"phone":32,"phoneExt":32,"email":32},"Xinhua Ye, MD, PhD",{"name":78,"role":82,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"facility":84,"status":68,"city":85,"state":70,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University","Nanjing","210000",{"type":57,"coordinates":88},[89,90],118.77778,32.06167,{"lat":90,"lon":89},[93,97,98],{"name":94,"role":40,"phone":95,"phoneExt":32,"email":96},"Jindan Wu, MD, PhD","86-025-52271000","wujindandan@sina.com",{"name":94,"role":37,"phone":32,"phoneExt":32,"email":32},{"name":99,"role":82,"phone":32,"phoneExt":32,"email":32},"Peng Zhang, MD",{"facility":101,"status":68,"city":85,"state":70,"zip":102,"country":54,"countryCode":55,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University","210008",{"type":57,"coordinates":104},[89,90],{"lat":90,"lon":89},[107,108,109,110],{"name":35,"role":40,"phone":45,"phoneExt":32,"email":42},{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},{"name":35,"role":37,"phone":32,"phoneExt":32,"email":32},{"name":44,"role":82,"phone":32,"phoneExt":32,"email":32},{"facility":112,"status":68,"city":85,"state":70,"zip":32,"country":54,"countryCode":55,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine",{"type":57,"coordinates":114},[89,90],{"lat":90,"lon":89},[117,119],{"name":118,"role":40,"phone":32,"phoneExt":32,"email":32},"Yueting Zhao, MD",{"name":118,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":121,"status":50,"city":122,"state":123,"zip":32,"country":54,"countryCode":55,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"The Second Affiliated Hospital of Dalian Medical University","Dalian","Liaoning",{"type":57,"coordinates":125},[126,127],121.60222,38.91222,{"lat":127,"lon":126},[130,132],{"name":131,"role":40,"phone":32,"phoneExt":32,"email":32},"Haixia Liu, MD, PhD",{"name":131,"role":37,"phone":32,"phoneExt":32,"email":32},{"facility":134,"status":68,"city":135,"state":136,"zip":137,"country":54,"countryCode":55,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Department of Endocrinology, Shanghai General Hospital","Shanghai","Shanghai Municipality","200080",{"type":57,"coordinates":139},[140,141],121.45806,31.22222,{"lat":141,"lon":140},[144,146],{"name":145,"role":40,"phone":32,"phoneExt":32,"email":32},"Fang Fang, MD, PhD",{"name":147,"role":37,"phone":32,"phoneExt":32,"email":32},"Fang Fang, MD,PhD",{"facility":149,"status":68,"city":135,"state":32,"zip":150,"country":54,"countryCode":55,"cosmosGeoPoint":151,"geoPoint":153,"contacts":154},"Department of Endocrinology, Huadong Hospital Affiliated to Fudan University","200040",{"type":57,"coordinates":152},[140,141],{"lat":141,"lon":140},[155,157,158],{"name":156,"role":40,"phone":32,"phoneExt":32,"email":32},"Bin Lu, MD, PhD",{"name":156,"role":37,"phone":32,"phoneExt":32,"email":32},{"name":159,"role":82,"phone":32,"phoneExt":32,"email":32},"Cuiping Jiang, MD",{"type":37,"investigatorFullName":161,"investigatorTitle":162,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Yan Bi","Chief Physician",[164,166,168,170,172,174,176],{"name":165,"class":6},"Nanjing First Hospital, Nanjing Medical University",{"name":167,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":169,"class":6},"Xiangya Hospital of Central South University",{"name":171,"class":6},"Huadong Hospital",{"name":173,"class":6},"Jiangsu Province Hospital of Traditional Chinese Medicine",{"name":175,"class":6},"Changzhou No.2 People's Hospital",{"name":121,"class":6},"100599335","phase-3-glp-1gcg-dual-agonist-in-type-2-diabetes-with-early-dementia-light-cog-study-100599335",false,"NCT07083154","GLP-1\u002FGCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)","Efficacy, Safety, and Tolerability of a GLP-1\u002FGCG Dual Receptor Agonist in Type 2 Diabetes With Early Dementia: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Type 2 diabetes mellitus (T2DM).\n2. Aged 50-75 years (inclusive), male or female.\n3. Early symptomatic dementia (Mild cognitive impairment or mild dementia), defined as:\n\n   1. MMSE score \\>20 and \\\u003C27,\n   2. CDR global score 0.5-1.0 (inclusive), with a CDR memory subscore ≥0.5,\n   3. Subjective memory complaints for ≥6 months.\n4. Stable glycemic control regimen for ≥3 months prior to screening, meeting one of the following:\n\n   1. Lifestyle\u002Fdietary intervention alone (no glucose-lowering drugs),\n   2. Oral antidiabetic drugs (OADs), with or without once-daily basal insulin.\n5. HbA1c 7.0-9.0% (inclusive) at screening.\n6. BMI ≥20 kg\u002Fm², with stable weight (fluctuation \\\u003C5%) for ≥3 months.\n7. Stable treatment regimen for cognitive impairment for at least 3 months prior to screening and commit to its continuation throughout the study period, meeting one of the following criteria:\n\n   1. No treatment: Not receiving any pharmacological or non-pharmacological interventions for cognitive impairment;\n   2. Non-pharmacological therapy only: Engaged exclusively in non-drug interventions (e.g., cognitive training);\n   3. Pharmacological therapy: Using approved symptomatic cognitive-enhancing medications (e.g., cholinesterase inhibitors, NMDA receptor antagonists), excluding disease-modifying therapies for Alzheimer's disease (AD).\n8. Ability to comply with systematic cognitive and functional assessments.\n9. Fully understands the trial protocol, voluntarily signs the informed consent form (ICF), and agrees to adhere to all study requirements and restrictions.\n\nExclusion Criteria:\n\n1. Evidence of other neurodegenerative diseases that may affect cognition, excluding Alzheimer's disease, including:\n\n   1. Frontotemporal dementia (FTD) and its variants\n   2. Parkinson's disease (PD), dementia with Lewy bodies (DLB)\n   3. Progressive supranuclear palsy (PSP), corticobasal degeneration (CBD)\n   4. Multiple system atrophy (MSA), multiple sclerosis (MS), Huntington's disease (HD), etc.\n2. Current diagnosis of a poorly controlled or unstable psychiatric disorder (including but not limited to schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders, etc.), which, in the investigator's judgment, may interfere with study assessments, affect treatment compliance, or increase participant risk.\n3. With a Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening, or a Generalized Anxiety Disorder Scale-7 (GAD-7) score ≥10 at screening.\n4. History of stroke (ischemic\u002Fhemorrhagic), transient ischemic attack (TIA), or epileptic seizure within 3 months prior to screening; Current or prior diagnosis of central nervous system (CNS) disorders that may impair cognitive function, including but not limited to:\n\n   CNS infections, Intracranial tumors, Metabolic encephalopathy, Neurological disorders due to malnutrition, or Severe traumatic brain injury.\n5. Acute hyperglycemic\u002Fhypoglycemic events within 1 year, including: Diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and Hypoglycemic coma\n6. Use of GLP-1R agonists, GLP-1R\u002FGIPR dual agonists, or GLP-1R\u002FGCGR dual agonists within 3 months prior to screening.\n7. Regular use (\\>2 doses\u002Fweek) of moderate-to-strong anticholinergic drugs within 4 weeks prior to screening; Use within 3 months prior to screening of: Anti-Parkinsonian drugs, Antiepileptic drugs, Antipsychotics, Morphine and opioid analgesics (Exemption: Short-term use \\[\\\u003C5 days\\] for surgery\u002Facute injury, if completed \\>4 weeks before screening); Use within 4 weeks prior to screening of: CNS stimulants; Medical\u002Frecreational cannabis, cannabinoids, or cannabidiol (CBD).a. Moderate\u002Fhigh anticholinergics, antiparkinsonian\u002Fantiepileptic drugs.\n8. Alcohol abuse (defined as \\>21 units\u002Fweek for men or \\>14 units\u002Fweek for women; 1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits).\n9. Medical history of:\n\n   1. Medullary thyroid carcinoma (MTC), pancreatitis\n   2. Multiple endocrine neoplasia type 2 (MEN2)\n   3. Gallbladder\u002Fbiliary disease, severe gastrointestinal disorders, or bowel resection\n   4. Active malignancy\n10. Uncontrolled or potentially unstable diabetic retinopathy\u002Fmaculopathy.\n11. Severe organ dysfunction, including:\n\n    1. ALT\u002FAST \\>3× upper limit of normal (ULN)\n    2. eGFR \\\u003C45 mL\u002Fmin\u002F1.73m² (CKD-EPI equation)\n    3. Unstable angina, myocardial infarction (MI), or NYHA Class II+ heart failure within 3 months\n12. Known\u002Fsuspected hypersensitivity to the investigational product or related compounds\n13. Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.\n14. MRI contraindications (e.g., metal implants, claustrophobia).\n15. Participation in other clinical trials within 3 months, involving an investigational medicinal product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.\n16. Any other condition deemed by the investigator to compromise safety or interfere with study assessments.","ALL","50 Years","75 Years",{"count":188,"type":189},420,"ESTIMATED","INTERVENTIONAL",[192],"PHASE3","The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.",[195,196,197],"Dementia, Mild","Mild Cognitive Impairment","Type 2 Diabetes",[197,199,196,200,201,202],"Mild Dementia","GLP-1\u002FGCG Dual Agonist","Cognitive Dysfunction","Early Dementia","2026-03-03",{"date":205,"type":206},"2026-03-05","ACTUAL",{"date":208,"type":206},"2025-09-27",{"date":210,"type":189},"2029-08-01",{"name":5,"class":6},8]