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
TREATMENT
Masking
QUADRUPLE
Enrollment
45
1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection
1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection
The First Affiliated hospital of USTC
Hefei, Anhui, China
RECRUITINGChange from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
Time frame: Week 26
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
Time frame: week 26
To assess the ADA
Time frame: week 26
To assess the number of patients with adverse events (AEs)
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: week 52\week 78
To assess the number of patients with clinically significant change in physical examination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in 12-ECG values,
Time frame: week 52\week 78
To assess the number of patients with clinically significant change in Head brain MRI
Time frame: week 52\week 78