NCT07579884尚未招募2 期
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
Risen (Suzhou) Pharma Tech Co., Ltd.0 个研究点目标入组 360 人开始时间: 2026年7月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •17-item Hamilton Depression Rating Scale (HAMD) total score ≤
- •Hachinski Ischemic Score (HIS) total score ≤ 4.
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
The participant will receive placebo
干预措施: Placebo (Drug)
研究者
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