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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
Placebo will be administered through IV infusion
Liverpool Hospital
Sydney, New South Wales, Australia
Southern Neurology
Sydney, New South Wales, Australia
Austin Health
Melbourne, Victoria, Australia
Adverse events(AEs)
To assess the number of patients with adverse events
Time frame: week 26
Baseline in vital signs value
To assess the number of patients with clinically significant change from baseline in vital signs value
Time frame: week 26
Physical examination
To assess the number of patients with clinically significant change in physical examination
Time frame: week 26
Laboratory examination
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: week 26
Baseline in 12-ECG values
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: week 26
MRI
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
Time frame: week 26
Aβ positron emission tomography (PET)
To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET)
Time frame: week 26
Concentrations of SHR-1707
To assess concentrations of SHR-1707 after multiple doses of administration
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Time frame: week 26
Anti-Drug antibody
To assess the incidence and time of occurrence of anti-SHR-1707 antibodies
Time frame: week 26