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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP902 low dose group | Experimental | The participant will receive RP902 200mg BID |
|
| RP902 high dose group | Experimental | The participant will receive RP902 400mg BID |
|
| Placebo | Placebo Comparator | The participant will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP902 | Drug | The participants will receive RP902 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan Wang | Contact | *86 21-61910060 | pan.wang@risen-group.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Tang | Xuanwu Hospital, Beijing | Principal Investigator |
| Yongjun Wang | Beijing Tiantan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | The participants will receive placebo |
|