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: week26
To assess the number of patients with adverse events (AEs),
Time frame: week 52\week78
To assess the number of patients with clinically significant change from baseline in vital signs values,
Time frame: week 52\week78
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To assess the number of patients with clinically significant change in physical examination,
Time frame: week 52\week78
To assess the number of patients with clinically significant change from baseline in laboratory examination,
Time frame: week 52\week78
To assess the number of patients with clinically significant change from baseline in 12-ECG values,
Time frame: week 52\week78
To assess the number of patients with clinically significant change in Head brain MRI (cerebral edema, microbleeding, etc.),
Time frame: week 52\week78