Mild Cognitive Impairment due to Alzheimer's Disease and mild Alzheimer's Disease
Conditions
Interventions
Dose1:A dose of 3 mg/kg
Dose3:A dose of 20mg/kg
Dose2:A dose of 10mg/kg
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily signed the informed consent form prior to any study-related procedures, and demonstrated willingness and ability to comply with all trial requirements. 2. Aged between 50 and 85 years (inclusive) at the time of signing the informed consent form, regardless of gender. 3. Have a body mass index (BMI) between 19 and 32 kg/m² (inclusive) during the screening or baseline period, with a body weight of >=45 kg and <=100 kg. 4. Must have a documented history of gradual memory decline with insidious onset and slow progression over the past 6 months prior to screening, which must be corroborated by an informant. 5. Must have a study partner (defined as an individual who can provide support throughout the study and spends at least 10 hours per week with the participant during waking hours, excluding time spent traveling to and from and being at the study site) who is willing to assist the participant for the entire trial duration. The study partner must also provide separate informed consent. 6. Must meet the diagnostic criteria for Mild Cognitive Impairment due to Alzheimer's Disease (AD-MCI) and mild Alzheimer's Disease as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA). 7. Must have a Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1 at screening. 8. Must have a Mini-Mental State Examination (MMSE) score between 20 and 28 (inclusive) at screening. 9. Must have a Modified Hachinski Ischemic Scale (MHIS) total score of <= 4 at screening. 10. Must have a 17-item Hamilton Depression Rating Scale (HDRS-17) total score of <= 10 at screening. 11. Must have a positive amyloid-beta (Aß) pathology result as assessed by brain Aß PET scan. 12. Patients, whether treatment-naïve or already receiving approved symptomatic AD medications (such as cholinesterase inhibitors or NMDA receptor antagonists) or other concomitant medications that may impact cognitive function, must have been on a stable dose for at least 1 month prior to randomization and are expected to maintain a stable dosage throughout the trial.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to the investigational product or any of its known components; or individuals with a specific history of allergies (e.g., asthma, urticaria, eczema) or those considered to be atopic; 2. MRI scan within 3 months prior to or during screening showing significant focal lesions, including any of the following: More than 2 cerebral infarct foci with a diameter greater than 2 cm. Infarcts in critical regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, or other cortical and subcortical gray matter nuclei. Cerebral white matter hyperintensity with a Fazekas Scale grade >= 3. Exception: Focal lesions deemed by the investigator as not affecting cognition or function. 3. Dementia due to other causes, including but not limited to: vascular cognitive impairment or dementia, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury-related dementia, other etiologies such as substance intoxication (e.g., drug, alcohol, carbon monoxide), significant systemic diseases (e.g., hepatic encephalopathy, pulmonary encephalopathy), intracranial space-occupying lesions (e.g., subdural hematoma, brain tumor), endocrine disorders (e.g., thyroid diseases), or deficiencies in vitamin B12 or folic acid, or any other known cause of dementia. 4. History of stroke, transient ischemic attack, neuromyelitis optica, Parkinson's disease onset, or epileptic seizure within 1 year prior to screening. 5. Presence of psychiatric disorders that, in the investigator's judgment, may interfere with study procedures or outcome assessments. 6. History of malignancy within 5 years prior to screening, with the exception of non-metastatic basal cell and/or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, non-progressive prostate cancer, or other cancers with a low risk of recurrence or spread. 7. Uncorrectable visual or hearing impairment that, in the investigator's opinion, prevents the completion of neuropsychological assessments. 8. Uncontrolled hypertension at screening: systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg at rest, and judged by the investigator as unsuitable for participation. 12-lead ECG at screening showing QTcF > 450 ms for males or > 470 ms for females, or severe arrhythmias (e.g., third-degree atrioventricular block, atrial fibrillation, etc.), and judged by the investigator as unsuitable for participation. 9. History of unstable angina or acute myocardial infarction within 6 months prior to screening. 10. Evidence of congestive heart failure, or history of end-stage cardiovascular disease (e.g., New York Heart Association [NYHA] Class III or IV chronic heart failure). 11. Clinically significant abnormal laboratory findings at screening, including: Liver function tests (ALT and/or AST) > 2 times the upper limit of normal (ULN). Renal function test (Creatinine) > 1.5 times ULN. Creatine kinase > 2 times ULN. Coagulation abnormalities (International Normalized Ratio [INR] >= 1.5; Activated Partial Thromboplastin Time [APTT] >= ULN + 10 seconds). 12. Positive for Hepatitis B surface antigen (HBsAg) with HBV-DNA > ULN, positive for Hepatitis C virus (HCV) antibody, positive for Human Immunodeficiency Virus (HIV) antibody, or positive for Treponema pallidum antibody. 13. Planned surgery during the trial period. 14. History of alcohol or s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Amyloid Plaque;Clinical Dementia Rating Scale Score;Activities of Daily Living Scale Score;Alzheimer's Disease Assessment Scale Score;Aß42?p-tau217;Mini-Mental State Examination Score;Pharmacokinetic (PK); | — |
Countries
China
Contacts
Public ContactTang Yi
Xuanwu Hospital, Capital Medical University
Outcome results
None listed