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NCT Number: NCT06619613

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Hefei, China

Location status: Recruiting

Location contact

Jiong Shi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alzheimer Disease (AD)

Biological

CM383 injection

Placebo

Other

Matched placebo

Primary outcomes

  1. Adverse event

    Time frame: Up to Week 26

    The occurrence of adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

86 + 02888610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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