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

Keymed Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer Disease

Treatments: Biological: Alzheimer Disease (AD); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619613

CM383-109001

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups

Group 1

Experimental group

Description:

CM383 injection, Intravenous infusion

Treatment:

Other: Placebo

Biological: Alzheimer Disease (AD)

Group 2

Experimental group

Description:

CM383 injection, Intravenous infusion

Treatment:

Other: Placebo

Biological: Alzheimer Disease (AD)

Group 3

Experimental group

Description:

CM383 injection, Intravenous infusion

Treatment:

Other: Placebo

Biological: Alzheimer Disease (AD)

Group 4

Experimental group

Description:

CM383 injection, Intravenous infusion

Treatment:

Other: Placebo

Biological: Alzheimer Disease (AD)