Not yet recruitingPhase 2

To Evaluate the Safety and Efficacy of RP902 Tablets

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

Lead sponsor

Risen (Suzhou) Pharma Tech Co., Ltd.

Asset

RP902

Listed sites

Recruiting sites

Enrollment

360

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE ≥24

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Identifiers

Registered as

NCT IDNCT07579884

Org study IDRP902-201

Timeline

Milestones

Study start2026-05estimated (month precision)

Study first posted2026-05-12actual

Last update posted2026-05-12actual

Primary completion2029-05estimated (month precision)

Study completion2031-05estimated (month precision)

Assets

Drug assets

RP902

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

1 endpoint

Primary/protocol endpoint

Clinical Dementia Rating Scale - Sum of Boxes

Time frame:Week 48

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.