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

NCT06619613 | Recruiting Phase 1

• 1 other identifier: CM383-109001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Adverse event

  The occurrence of adverse events.

  Up to Week 26

Study Arms (4)

Group 1

EXPERIMENTAL

CM383 injection, Intravenous infusion

Biological: Alzheimer Disease (AD); Other: Placebo

Group 2

EXPERIMENTAL

CM383 injection, Intravenous infusion

Biological: Alzheimer Disease (AD); Other: Placebo

Group 3

EXPERIMENTAL

CM383 injection, Intravenous infusion

Biological: Alzheimer Disease (AD); Other: Placebo

Group 4

EXPERIMENTAL

CM383 injection, Intravenous infusion

Biological: Alzheimer Disease (AD); Other: Placebo

Interventions

Alzheimer Disease (AD) BIOLOGICAL

CM383 injection

Group 1; Group 2; Group 3; Group 4

Placebo OTHER

Matched placebo

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

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

Hefei, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jiong Shi

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

86 + 02888610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CN (1)