Actively Recruiting
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
Led by Keymed Biosciences Co.Ltd · Updated on 2025-03-19
48
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
- Be between 50 and 85 years old.
- Have a BMI between 19 kg/m2 and 32.5 kg/m2, and a weight between 45 kg and 100 kg at screening or baseline.
You will not qualify if you...
- Cognitive impairment caused by medical or neurological issues other than Alzheimer's disease.
- History of stroke, transient ischemic attack, seizures, or unexplained loss of consciousness within the past year.
- Presence of any mental illness that could affect cognitive assessments.
- History of moderate or severe kidney dysfunction.
- Uncontrolled stable high blood pressure.
- History of severe trauma or major surgery within 6 months before screening, or planned surgery during the study.
- History of cancer within 5 years before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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