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To Evaluate the Safety and Efficacy of RP902 Tablets
Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.
Summary
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).
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
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-07
Completion Date
2031-05
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
RP902
The participants will receive RP902
Placebo
The participants will receive placebo