To Evaluate the Safety and Efficacy of RP902 Tablets

NCT07579884 | Not Yet Recruiting Phase 2

• 1 other identifier: RP902-201
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Clinical Dementia Rating Scale - Sum of Boxes

  Change from baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48

  Week 48

Study Arms (3)

RP902 low dose group

EXPERIMENTAL

The participant will receive RP902 200mg BID

Drug: RP902

RP902 high dose group

EXPERIMENTAL

The participant will receive RP902 400mg BID

Drug: RP902

Placebo

PLACEBO COMPARATOR

The participant will receive placebo

Drug: Placebo

Interventions

RP902 DRUG

The participants will receive RP902

RP902 high dose group; RP902 low dose group

Placebo DRUG

The participants will receive placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• item Hamilton Depression Rating Scale (HAMD) total score ≤ 10.
• Hachinski Ischemic Score (HIS) total score ≤ 4.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yi Tang

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Yongjun Wang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Wang

CONTACT

*86 21-61910060; pan.wang@risen-group.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share