A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alzheimer Disease (AD), Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological Alzheimer Disease (AD)
CM383 injection - Other Placebo
Matched placebo
Primary outcome measures
- Adverse event [Time frame: Up to Week 26]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
Identifiers
NCT: NCT06619613 · CM383-109001