Evaluating CM383 for 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
This study is testing a new medication called CM383 to see if it can help people with mild cognitive impairment and mild Alzheimer's disease feel better and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Hefei) |
| Trial ID | NCT06619613 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 85 years with a diagnosis of mild cognitive impairment or mild Alzheimer's disease.
Not a fit: Patients with cognitive impairment due to other medical or neurological factors, or those with significant comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with mild cognitive impairment and mild Alzheimer's disease.
How similar studies have performed: Other studies have explored similar interventions in Alzheimer's disease, but the specific approach of CM383 is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.