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This is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | CM383 injection, Intravenous infusion |
|
| Group 2 | Experimental | CM383 injection, Intravenous infusion |
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| Group 3 | Experimental | CM383 injection, Intravenous infusion |
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| Group 4 | Experimental | CM383 injection, Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alzheimer Disease (AD) | Biological | CM383 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | The occurrence of adverse events. | Up to Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 86 + 02888610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiong Shi | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Other | Matched placebo |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |