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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-85
SponsorKeymed Biosciences Co.Ltd

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Alzheimer Disease (AD)
  • Placebo

Treatment groups

48 Participants
are divided into 4 treatment groups

Sponsors and collaborators