NCT06619613 · Phase 1 · RECRUITING
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
This trial is testing CM383, a biological drug, in people who have mild cognitive impairment or mild Alzheimer's disease. It is a Phase 1b study, meaning the main goals right now are safety, tolerability, and understanding how the drug behaves in the body — not yet proving it works. Participants receive either CM383 or a placebo, with doses increasing over time to find a safe range.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-03-19