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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
33
Multiple-ascending Dose
Multiple-ascending Dose
The First Affiliated Hospital Of USTC
Hefei, Anhui, China
To assess the number of patients with adverse events (AEs)
Time frame: Week 26
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: Week 26
To assess the number of patients with clinically significant change in physical examination
Time frame: Week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: Week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: Week 26
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
Time frame: Week 26
To assess the change from baseline in Brain Amyloid Plaque Deposition as measured by Aβ PET
Time frame: Week26/52/78
To assess the ADA
Time frame: Week 26
To assess the number of patients with adverse events (AEs)
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: Week 52/78
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To assess the number of patients with clinically significant change in physical examination
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: Week 52/78
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: Week 52/78
To assess the number of patients with clinically significant change in Head brain MRI (cerebral edema, microbleeding, etc.)
Time frame: Week 52/78