Status:
NOT_YET_RECRUITING
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Alzheimer Disease (AD)
Alzheimer Dementia
Eligibility:
All Genders
50-85 years
Brief Summary
Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate sta...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. \[Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology\]
- Male or Female
- Between 50 and 85 years old (inclusive)
- Not currently participating in any other clinical trial or research study
- Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form
- Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion
Exclusion
- Any contraindication to MRI
- History of seizure within the past 6 months or refractory epilepsy.
- Unstable or severe psychiatric illness within the past 6 months.
- History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \<50,000/μL or INR \>1.5).
- Uncontrolled diabetes mellitus or hypertension.
- History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.
- Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).
- Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.
- Breastfeeding individuals or women of childbearing potential not using highly effective contraception.
- History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07152418
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 3 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.