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

NCT06619613 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

Alzheimer Disease (AD)

CM383 injection

OTHER

Placebo

Matched placebo

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Jiong Shi · The First Affiliated Hospital of University of Science and Technology of China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619613 on ClinicalTrials.gov