Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥50 and ≤85 on the date of signing the informed consent, males or females; 2. BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤100 kg at screening or baseline； 3. must meet the diagnostic criteria for MCI due to AD or mild AD; 4. The total score of HAMD-17 should be ≤10 scores at screening; 5. The score of Hachinski ischemic scale should be ≤4 scores at screening; 6. amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD; 7. Agreed to test ApoE genotype; 8. Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 1 months prior to the screening visit; Exclusion Criteria: 1. Cognitive impairment of subjects due to other medical or neurological factors (other than AD); 2. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year; 3. Any psychiatric diagnosis that may interfere with the subject's cognitive assessmen