Alzheimer's Disease (AD)
Conditions
Brief summary
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.
Interventions
DRUGSHR-1707 injection
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
DRUGPlacebo
Placebo will be administered through IV infusion
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
SHR-1707 injection compared with placebo
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial, 2. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form. 3. Total body weight of 45\ 100 kg (inclusive), with a body mass index (BMI) of 19\ 32 kg/m2 (inclusive)at screening or baseline. 4. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD. 5. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.
Exclusion criteria
1. Cognitive impairment due to other medical or neurological factors (non-AD). 2. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year. 3. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment. 4. Inability to tolerate MRI examination or have contraindications to MRI examination. 6\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI | week 26 | To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.) |
| Physical examination | week 26 | To assess the number of patients with clinically significant change in physical examination |
| Laboratory examination | week 26 | To assess the number of patients with clinically significant change from baseline in laboratory examination |
| Baseline in 12-ECG values | week 26 | To assess the number of patients with clinically significant change from baseline in 12-ECG values |
| Adverse events(AEs) | week 26 | To assess the number of patients with adverse events |
| Baseline in vital signs value | week 26 | To assess the number of patients with clinically significant change from baseline in vital signs value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of SHR-1707 | week 26 | To assess concentrations of SHR-1707 after multiple doses of administration |
| Anti-Drug antibody | week 26 | To assess the incidence and time of occurrence of anti-SHR-1707 antibodies |
| Aβ positron emission tomography (PET) | week 26 | To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET) |
Countries
Australia
Outcome results
None listed