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

Last updated: March 14, 2025
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Dementia

Mental Disability

Memory Loss

Treatment

Alzheimer Disease (AD)

Placebo

Clinical Study ID

NCT06619613
CM383-109001
  • Ages 50-85
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily participate and have the subject and their legal guardian jointly signthe 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

Exclusion Criteria:

  • Cognitive impairment of subjects due to other medical or neurological factors (otherthan AD)

  • History of stroke or transient ischemic attack, seizures, or other unexplained lossof consciousness within the past year

  • With any mental illness that may interfere with the cognitive assessment of thesubjects.

  • 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 thescreening period, or planned surgery during the study.

  • History of malignancy within 5 years prior to screening.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Alzheimer Disease (AD)
Phase: 1
Study Start date:
November 08, 2024
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei,
    China

    Active - Recruiting

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