NCT06619613RecruitingPhase 1
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- 8 Nov 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Alzheimer disease
- NCT number
- NCT06619613
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From 8 Nov 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
Other illness
- 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.
- History of malignancy within 5 years prior to screening.
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.