To Evaluate the Safety and Efficacy of RP902 Tablets

Официальное название

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

Обзор

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).

Вмешательства

• Препарат RP902
  The participants will receive RP902
• Препарат Placebo
  The participants will receive placebo

Первичные конечные точки

• Clinical Dementia Rating Scale - Sum of Boxes [Срок оценки: Week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07579884 · RP902-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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