Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1707 | Experimental | Up to4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 injection |
|
| SHR-1707 placebo | Placebo Comparator | Up to 4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1707 | Drug | Multiple-ascending Dose |
| |
| SHR-1707 placebo |
| 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 | |
| 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 (cerebral edema, microbleeding, etc.) | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change from baseline in Brain Amyloid Plaque Deposition as measured by Aβ PET | Week26/52/78 | |
| To assess the ADA | Week 26 | |
| To assess the number of patients with adverse events (AEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of USTC | Hefei | Anhui | 230001 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
SHR-1707 injection compared with placebo
Not provided
Not provided
Not provided
| Drug |
Multiple-ascending Dose |
|
| Week 52/78 |
| To assess the number of patients with clinically significant change from baseline in vital signs values | Week 52/78 |
| To assess the number of patients with clinically significant change in physical examination | Week 52/78 |
| To assess the number of patients with clinically significant change from baseline in laboratory examination | Week 52/78 |
| To assess the number of patients with clinically significant change from baseline in 12-ECG values | Week 52/78 |
| To assess the number of patients with clinically significant change in Head brain MRI (cerebral edema, microbleeding, etc.) | Week 52/78 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |