Alzheimer Disease
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.
Interventions
BIOLOGICALAlzheimer Disease (AD)
CM383 injection
OTHERPlacebo
Matched placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form. * The age of the subjects is between 50 and 85 years old. * BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.
Exclusion criteria
* Cognitive impairment of subjects due to other medical or neurological factors (other than AD) * History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year * With any mental illness that may interfere with the cognitive assessment of the subjects. * With history of moderate or severe renal dysfunction. * With Uncontrolled stable hypertension. * With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study. * History of malignancy within 5 years prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Up to Week 26 | The occurrence of adverse events. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed