RP902 tablets for mild cognitive impairment (MCI)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study will enroll about 360 participants at up to 50 sites in China to test RP902 tablets versus placebo over 48 weeks, with optional extension and safety follow-up. Participants must have MCI per NIA-AA criteria, MMSE ≥ 24, CDR-GS 0.5, memory ≥ 0.5, and low depression and vascular risk scores. The trial includes a screening period (up to 4 weeks), a 48-week treatment period, and an optional extension (96 weeks) or a 4-week post-dose safety follow-up. The study aims to inform the design of a potential Phase III trial and assess preliminary efficacy and safety in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Pan Wang
• Email: pan.wang@risen-group.com
• Phone: *86 21-61910060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.