Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

Zhejiang University

Status

Not yet enrolling

Conditions

Alzheimer Dementia

Mild Cognitive Impairment (MCI)

Alzheimer Disease (AD)

Treatments

Drug: Conventional anti-dementia treatment group

Biological: Lecanemab 10 mg/kg

Study type

Observational

Funder types

Other

Identifiers

NCT07152418

2025-0466

Details and patient eligibility

About

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 stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.

Enrollment

120 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.