A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease

Phase 1

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Biological: Alzheimer Disease (AD); Other: Placebo

• Registration Number: NCT06619613
• Lead Sponsor: Keymed Biosciences Co.Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-11-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3	Placebo	CM383 injection, Intravenous infusion
Group 4	Alzheimer Disease (AD)	CM383 injection, Intravenous infusion
Group 4	Placebo	CM383 injection, Intravenous infusion
Group 1	Alzheimer Disease (AD)	CM383 injection, Intravenous infusion
Group 1	Placebo	CM383 injection, Intravenous infusion
Group 2	Alzheimer Disease (AD)	CM383 injection, Intravenous infusion
Group 2	Placebo	CM383 injection, Intravenous infusion
Group 3	Alzheimer Disease (AD)	CM383 injection, Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Adverse event	Up to Week 26	The occurrence of adverse events.

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China; 🇨🇳 Hefei, China