A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Aβ-PET centiloid values
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Lecanemab treatment group
Lecanemab 10 mg/kg
干预措施: Lecanemab 10 mg/kg (Biological)
Conventional anti-dementia treatment
Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.
干预措施: Conventional anti-dementia treatment group (Drug)
结局指标
主要结局
Aβ-PET centiloid values
时间窗: Baseline, 18 months
Statistical Comparison of Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores
次要结局
- Change from Baseline in the CDR at 18 Months(Baseline, 18 months)
- Change from Baseline in the MMSE at 18 Months(Baseline, 18 months)
- Change from Baseline in the MoCA at 18 Months(Baseline, 18 months)
- Change from Baseline in the NPI at 18 Months(Baseline, 18 months)
- Blood AD molecular pathology(Baseline, 6 months, 12 months, 18 months)