To Evaluate the Safety and Efficacy of RP902 Tablets

Sponsor
Risen (Suzhou) Pharma Tech Co., Ltd.
Study ID
NCT07579884
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RP902 — DRUG
    The participants will receive RP902
  • Placebo — DRUG
    The participants will receive placebo

Study Details

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).

Key Dates

First listed
May 12, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2031

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RP902 low dose group
    The participant will receive RP902 200mg BID
  • Experimental: RP902 high dose group
    The participant will receive RP902 400mg BID
  • Placebo Comparator: Placebo
    The participant will receive placebo

Primary Outcome Measure

Clinical Dementia Rating Scale - Sum of Boxes [ Time Frame: Week 48 ]

Central Contacts

Related Studies