A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
NCT ID: NCT06619613
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2024-11-08
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
CM383 injection, Intravenous infusion
Alzheimer Disease (AD)
CM383 injection
Placebo
Matched placebo
Group 2
CM383 injection, Intravenous infusion
Alzheimer Disease (AD)
CM383 injection
Placebo
Matched placebo
Group 3
CM383 injection, Intravenous infusion
Alzheimer Disease (AD)
CM383 injection
Placebo
Matched placebo
Group 4
CM383 injection, Intravenous infusion
Alzheimer Disease (AD)
CM383 injection
Placebo
Matched placebo
Interventions
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Alzheimer Disease (AD)
CM383 injection
Placebo
Matched placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jiong Shi
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, , China
Countries
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Central Contacts
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Facility Contacts
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Jiong Shi
Role: primary
Other Identifiers
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CM383-109001
Identifier Type: -
Identifier Source: org_study_id
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