To Evaluate the Safety and Efficacy of RP902 Tablets

NCT ID
NCT07579884
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Risen (Suzhou) Pharma Tech Co., Ltd.
Conditions
Mild Cognitive Impairment (MCI)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 360 participants (Estimated).

What is being studied

  • Drug: Placebo
  • Drug: RP902

Who may be eligible

Ages
50 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Voluntary participation and signed informed consent form. * Junior high school graduation or above, capable of completing cognitive function assessments and other tests specified in the protocol. * Meet the core clinical diagnostic criteria for mild cognitive impairment (MCI) of the National Institute on Aging-Alzheimer's Association (NIA-AA) (2024). * Mini-Mental State Examination (MMSE) score ≥ 24; Clinical Dementia Rating-Global Score (CDR-GS) = 0.5, with memory score ≥ 0.5. * 17-item Hamilton Depression Rating Scale (HAMD) total score ≤ 10. * Hachinski Ischemic Score (HIS) total score ≤ 4. Exclusion Criteria: * Dementia caused by other etiologies. * Neurological diseases other than Alzheimer's Disease (AD). * Positive hepatitis B surface antigen (HBsAg) and/or 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). * Active systemic bacterial, viral, fungal or parasitic infection, or other clinically significant active infections deemed unsuitable by the investigator. * Male: QTcF \> 450 ms; Female: QTcF \> 470 ms, or other clinically significant abnormal electrocardiogram deemed unsuitable. * Severe or poorly controlled cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological diseases (except AD) within 6 months prior to screening visit. * 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). * 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). * 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. * History of alcohol abuse or drug abuse within 1 year prior to screening visit. * History of severe drug allergy or multiple drug allergies. * Lactating women. * Other conditions deemed unsuitable for the study by the investigator. * Trial Groups

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.

Countries: China

  • Beijing Municipality, China: 2

Sample of listed locations

  • Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, 100070, China — Recruiting
  • Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, 100053, China — Recruiting

Study details

Start date
July 14, 2026
Primary completion date
May 1, 2029
Completion date
May 1, 2031
First posted
May 12, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07579884
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07579884 on ClinicalTrials.gov

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