NCT07152418Not yet recruiting
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Alzheimer disease
- NCT number
- NCT07152418
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of seizure within the past 6 months or refractory epilepsy.
- Unstable or severe psychiatric illness within the past 6 months.
- 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.
- History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.
Lab values
- History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \<50,000/μL or INR \>1.5).
Other
- Any contraindication to MRI
- Breastfeeding individuals or women of childbearing potential not using highly effective contraception.
Who the study is looking for
- 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
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.