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Based on the adjustment of the sponsor's R&D strategy, it is decided to terminate this study in advance.
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Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1707 | Experimental |
| |
| SHR-1707 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1707 | Drug | 1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the number of patients with adverse events (AEs) | week 26 | |
| To assess the number of patients with clinically significant change from baseline in vital signs values | week 26 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated hospital of USTC | Hefei | Anhui | 230000 | 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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SHR-1707 compared with placebo
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| SHR-1707 placebo | Drug | 1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection |
|
| To assess the number of patients with clinically significant change in physical examination |
| week 26 |
| To assess the number of patients with clinically significant change from baseline in laboratory examination | week 26 |
| To assess the number of patients with clinically significant change from baseline in 12-ECG values | week 26 |
| To assess the number of patients with clinically significant change in brain MRI | week 26 |
| To assess the ADA | week 26 |
| To assess the number of patients with adverse events (AEs) | week 52\week 78 |
| To assess the number of patients with clinically significant change from baseline in vital signs values | week 52\week 78 |
| To assess the number of patients with clinically significant change in physical examination | week 52\week 78 |
| To assess the number of patients with clinically significant change from baseline in laboratory examination | week 52\week 78 |
| To assess the number of patients with clinically significant change from baseline in 12-ECG values, | week 52\week 78 |
| To assess the number of patients with clinically significant change in Head brain MRI | week 52\week 78 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |