A 12-month Single-arm Real-world Study to Determine the Safety and Efficacy of Lecanemab in Patients With Early Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR)
研究概览
简要总结
This is a 12-month, single-arm, real-world study designed to evaluate the efficacy and safety of lecanemab (10 mg/kg administered every two weeks) in patients with early Alzheimer's disease, including mild cognitive impairment (MCI) due to AD or mild AD dementia, confirmed by amyloid-positive Aβ-PET scans. The study will enroll 80 participants, with both retrospective and prospective data collection.
详细描述
The study enrolled participants with mild cognitive impairment due to AD or mild AD. All participants received biweekly intravenous infusions of lecanemab at a dose of 10 mg/kg. Safety data was collected, particularly for amyloid-related imaging abnormalities (ARIA). Effectiveness evaluations included cognitive tests, plasma biomarker analysis, and advanced neuroimaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the NIA-AA 2011 diagnostic criteria for:
- •Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD) or Mild Alzheimer's Disease Dementia.
- •Confirmed Aβ pathology by: Aβ-PET scan or CSF Aβ42/Aβ40 ratio (results within 6 months prior to screening).
- •Cognitive scales (within 3 months): Clinical Dementia Rating (CDR) global score 0.5-1 and/or Mini-Mental State Examination (MMSE) score 20-
- •APOE genotype results available.
- •MRI/SWI eligibility:
- •No exclusionary findings (see Exclusion Criteria for details).
- •Laboratory tests within normal ranges or deemed non-clinically significant by the investigator:
- •Routine tests: Liver/kidney function, CBC, urinalysis, fecal occult blood. Thyroid function: Free T3, free T4, TSH. Vitamin B12 (and methylmalonic acid [MMA], if available). Coagulation panel: PT/INR, aPTT (required). Negative for syphilis, HIV, or other infections that may affect cognition.
排除标准
- •MRI/SWI exclusionary findings: 4 microhemorrhages (maximum diameter ≤10 mm). Any macrohemorrhage (>10 mm in diameter). Cortical superficial siderosis. Vasogenic edema. Evidence of brain contusion, encephalomalacia, vascular malformations, or infectious lesions.
- •Multiple lacunar infarcts/strokes in major vascular territories, severe small vessel disease, or severe white matter lesions (Fazekas grade ≥3).
- •Space-occupying lesions or brain tumors (except asymptomatic meningiomas/arachnoid cysts <1 cm).
研究组 & 干预措施
Lecanemab treatment group
receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes.
干预措施: Administer Leqemi 10 mg/kg, every two weeks. (Drug)
结局指标
主要结局
Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR)
时间窗: Baseline, 6 months, 12 months
Measurement: Unit of Measure: SUVR (unitless ratio) Reference Region: Cerebellar gray matter Range: Typically 1.0-3.0 in amyloid-positive subjects Direction: Lower values indicate greater amyloid clearance
Change in Amyloid Burden as Assessed by Centiloid Scale
时间窗: Baseline, 6 months, 12 months
Measurement: Unit of Measure: Centiloids (CL) Scale Range: 0 CL: Young healthy controls 100 CL: Typical Alzheimer's dementia threshold Direction: Lower values indicate greater amyloid clearance
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)(0-12 months (continuous monitoring))
- Change in Cognitive Function as Assessed by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)(Baseline, 3 months, 6 months, 12 months)
- Change in Cognitive Function as Assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)(Baseline, 3 months, 6 months, 12 months)
- Change in Cognitive Function as Assessed by Mini-Mental State Examination (MMSE)(Baseline, 3 months, 6 months, 12 months)
- Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI)(Baseline, 3 months, 6 months, 12 months)
- Change in Functional Abilities as Assessed by the Alzheimer's Disease Cooperative Study-Activities of Daily Living for Mild Cognitive Impairment (ADCS MCI-ADL)(Baseline, 3 months, 6 months, 12 months)
- Change in Caregiver Burden as Assessed by the Zarit Burden Interview (ZBI)(Baseline, 3 months, 6 months, 12 months)
研究者
WENYAN KANG
Professor and Chief Physician, Department of Neurology
Ruijin Hospital