[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640309":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":42,"locations":30,"responsibleParty":48,"collaborators":30,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":30,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":30,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":30,"overallStatus":69,"whyStopped":30,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":30},{"fullName":5,"class":6},"Risen (Suzhou) Pharma Tech Co., Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"RP902 low dose group","EXPERIMENTAL","The participant will receive RP902 200mg BID",[13],"Drug: RP902",{"label":15,"type":10,"description":16,"interventionNames":17},"RP902 high dose group","The participant will receive RP902 400mg BID",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","The participant will receive placebo",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","RP902","The participants will receive RP902",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"The participants will receive placebo",[19],[35,39],{"name":36,"affiliation":37,"role":38},"Yi Tang","Xuanwu Hospital, Beijing","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Yongjun Wang","Beijing Tiantan Hospital",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Pan Wang","CONTACT","*86 21-61910060","pan.wang@risen-group.com",{"type":49,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100640309","phase-2-to-evaluate-the-safety-and-efficacy-of-rp902-tablets-100640309",false,"NCT07579884","To Evaluate the Safety and Efficacy of RP902 Tablets","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of RP902 Tablets in the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease","Inclusion Criteria:\n\n* Voluntary participation and signed informed consent form.\n* Junior high school graduation or above, capable of completing cognitive function assessments and other tests specified in the protocol.\n* Meet the core clinical diagnostic criteria for mild cognitive impairment (MCI) of the National Institute on Aging-Alzheimer's Association (NIA-AA) (2024).\n* Mini-Mental State Examination (MMSE) score ≥ 24; Clinical Dementia Rating-Global Score (CDR-GS) = 0.5, with memory score ≥ 0.5.\n* 17-item Hamilton Depression Rating Scale (HAMD) total score ≤ 10.\n* Hachinski Ischemic Score (HIS) total score ≤ 4.\n\nExclusion Criteria:\n\n* Dementia caused by other etiologies.\n* Neurological diseases other than Alzheimer's Disease (AD).\n* Positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with positive HBV-DNA copy number (above upper limit of normal range); positive hepatitis C virus antibody (HCV Ab) with positive HCV RNA; positive human immunodeficiency virus antibody (HIV Ab); positive Treponema pallidum antibody (TP Ab).\n* Active systemic bacterial, viral, fungal or parasitic infection, or other clinically significant active infections deemed unsuitable by the investigator.\n* Male: QTcF \\> 450 ms; Female: QTcF \\> 470 ms, or other clinically significant abnormal electrocardiogram deemed unsuitable.\n* Severe or poorly controlled cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological diseases (except AD) within 6 months prior to screening visit.\n* History of active peptic ulcer, inflammatory bowel disease, or other severe gastrointestinal diseases affecting drug absorption within 6 months prior to screening visit; or history of gastrointestinal bleeding, perforation or gastrointestinal surgery within 5 years (excluding appendectomy, polypectomy, hemorrhoid surgery).\n* Malignant tumor diagnosed within 3 years prior to screening (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and radically resected carcinoma in situ).\n* Participation in other clinical trials within 3 months prior to randomization; subjects in non-interventional observational studies may be included if judged by the investigator to have no interference with the safety and efficacy of the study drug.\n* History of alcohol abuse or drug abuse within 1 year prior to screening visit.\n* History of severe drug allergy or multiple drug allergies.\n* Lactating women.\n* Other conditions deemed unsuitable for the study by the investigator.\n* Trial Groups","ALL","50 Years","85 Years",{"count":61,"type":62},360,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","The purpose of the study is to evaluate the preliminary efficacy of RP902 Tablets in participants with Alzheimer's disease (AD)-derived mild cognitive impairment (MCI) and provide a design basis for the Phase III study. This Phase II study plans to enroll 360 participants and will be conducted at approximately 50 sites in China. The study consists of a Screening Period (up to 4 weeks) and a double-blind treatment period (48 weeks). After completing the 48-week double-blind treatment period, participants may choose to continue into an extension treatment period (96 weeks) or undergo safety follow-up (4 weeks after the last dose).",[68],"Mild Cognitive Impairment (MCI)","NOT_YET_RECRUITING","2026-07-31",{"date":72,"type":73},"2026-08-03","ACTUAL",{"date":75,"type":62},"2026-07",{"date":77,"type":62},"2031-05",{"name":5,"class":6}]