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To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 SHR-1707 | Experimental | SHR-1707 is administered intravenously. |
|
| Dose level 1 Placebo | Placebo Comparator | Placebo is administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1707 injection | Drug | Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events(AEs) | To assess the number of patients with adverse events | week 26 |
| Baseline in vital signs value | To assess the number of patients with clinically significant change from baseline in vital signs value | week 26 |
| Physical examination | To assess the number of patients with clinically significant change in physical examination | week 26 |
| Laboratory examination | To assess the number of patients with clinically significant change from baseline in laboratory examination | week 26 |
| Baseline in 12-ECG values | To assess the number of patients with clinically significant change from baseline in 12-ECG values | week 26 |
| MRI | To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.) | week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Aβ positron emission tomography (PET) | To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET) | week 26 |
| Concentrations of SHR-1707 |
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Inclusion Criteria:
Exclusion Criteria:
6. Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
7. Exclusion criteria related to general or laboratory tests, as listed in the protocol.
8. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
9. Severe visual or hearing impairment, unable to cooperate in the scale examination.
10. Patients suspected to be allergic to Aβ antibody drugs and their excipients.
11. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.
12. History of drug abuse and/or drug addiction within 1 year prior to screening.
13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.
14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.
15. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.
16. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
17. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Sydney | New South Wales | Australia | |||
| Southern Neurology |
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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 injection compared with placebo
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| Placebo | Drug | Placebo will be administered through IV infusion |
|
To assess concentrations of SHR-1707 after multiple doses of administration
| week 26 |
| Anti-Drug antibody | To assess the incidence and time of occurrence of anti-SHR-1707 antibodies | week 26 |
| Sydney |
| New South Wales |
| Australia |
| Austin Health | Melbourne | Victoria | Australia |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |