NCT06619613 A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
| NCT ID | NCT06619613 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2024-11-08 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Jiong Shi
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT06619613 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06619613 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06619613 currently recruiting?
Yes, NCT06619613 is actively recruiting participants. Contact the research team at qianjia@keymedbio.com for enrollment information.
Where is the NCT06619613 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06619613 clinical trial?
NCT06619613 is sponsored by Keymed Biosciences Co.Ltd. The principal investigator is Jiong Shi at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 48 participants.
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