Evaluating CM383 for Mild Cognitive Impairment and Mild Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients diagnosed with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease. It employs a randomized, double-blind, placebo-controlled methodology with multiple dose escalations to ensure rigorous evaluation. Participants will be monitored closely to gather data on the drug's effects and potential benefits over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, China Recruiting

Study contacts

• Principal investigator: Jiong Shi — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Qian Jia
• Email: qianjia@keymedbio.com
• Phone: 86 + 02888610620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.