Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
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: Lecanemab 10 mg/kg, Conventional anti-dementia treatment group.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease (AD), Alzheimer Dementia, Mild Cognitive Impairment (MCI). 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
- Center list to be confirmed — check the primary protocol.
- 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 Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
Overview
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.
Interventions
- Biological Lecanemab 10 mg/kg
Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a term - Drug Conventional anti-dementia treatment group
Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.
Primary outcome measures
- Aβ-PET centiloid values [Time frame: Baseline, 18 months]
Secondary outcome measures (5)
- Change from Baseline in the CDR at 18 Months [Time frame: Baseline, 18 months]
- Change from Baseline in the MMSE at 18 Months [Time frame: Baseline, 18 months]
- Change from Baseline in the MoCA at 18 Months [Time frame: Baseline, 18 months]
- Change from Baseline in the NPI at 18 Months [Time frame: Baseline, 18 months]
- Blood AD molecular pathology [Time frame: Baseline, 6 months, 12 months, 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07152418 · 2025-0466