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NCT Number: NCT07579884

To Evaluate the Safety and Efficacy of RP902 Tablets

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).

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

RP902

Drug

The participants will receive RP902

Placebo

Drug

The participants will receive placebo

Primary outcomes

  1. Clinical Dementia Rating Scale - Sum of Boxes

    Time frame: Week 48

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pan Wang

CONTACT

[email protected]

*86 21-61910060

Sponsors and collaborators

Lead sponsor

Risen (Suzhou) Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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