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To Evaluate the Safety and Efficacy of RP902 Tablets

NCT07579884 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-12

No results posted yet for this study

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).

Conditions

  • Mild Cognitive Impairment (MCI)

Interventions

DRUG

RP902

The participants will receive RP902

DRUG

Placebo

The participants will receive placebo

Sponsors & Collaborators

  • Risen (Suzhou) Pharma Tech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Tang · Xuanwu Hospital, Beijing

  • Yongjun Wang · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-05-31
Completion
2031-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579884 on ClinicalTrials.gov