Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in amyloid dposition on amyloid imaging scans
研究概览
简要总结
This study aimed to determine the efficacy of amyloid clearance of lecanemab in patients with Parkinson's disease (PD) with amyloid co-pathology. Lecanemab, an anti-amyloid monoclonal antibody, was apporoved by the US FDA in July 2023 and in South Korea in May 2024, as a disease-modifying therapy based on its clinical efficacy and reduction of amyloid plaques in patients with early-stage Alzheimer's disease (AD). AD pathology is also common in PD, and approximately 35% of patients with PD dementia have co-existing AD pathology. Currently, no mediations have been developed to slow the progression of PD. Therefore, this study aimed to determine whether reducing the amyloid burden in patients with PD with co-exsistent AD pathology could potentially slow disease progression. To test it, patients with PD with mild cognitive impairment or early dementia, who were confirmed to have amyloid deposition through amyloid imaging, would be enrolled as a treatment arm, and the degree of reduction of amyloid plaque after 18 months of lecanemab administration would be investigated.
详细描述
This study plans to consecutively enroll the patients with Parkinson's disease (PD) who have confirmed amyloid deposition on amyloid imaging and meet the indications for lecanemab administration. After a thorough explanation of lecanemab administration, patients who consent to the treatment would be enrolled. Patients assinged to the treatment arm would receive standard lecanemab treatment (10mg/kg intravenous infusion every two weeks for 18 months) and standard PD care. Patients who do not consent to the administration of lecanemab would receive stadnard care for PD and be monitored their progress without any further intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients diagnosed with Parkinson's disease
- •Amyloid deposition confirmed by FBB PET
- •Mild cognitive impairment or early dementia (CDR 0.5 or 1) on neuropsychological tests
- •Adults aged 50-90 years
排除标准
- •Cases in which lecanemab administration is contraindicated (based on recommendations from the Korean Dementia Association)
- •Cases in which neuropathologies other than Parkinson's disease or Alzheimer's disease are suspected as the underlying disease
研究组 & 干预措施
Lecanemab non-admnistration group
Patients who do not receive lecanemab
干预措施: Lecanemab non-administration group (Other)
Lecanemab admnistration group
Patients who receive lecanemab 10mg/kg every two weeks for 18 months
干预措施: Lecanemab (Drug)
结局指标
主要结局
Changes in amyloid dposition on amyloid imaging scans
时间窗: Change from baseline to 18 months
Changes in amyloid dposition (i.e., global FBB SUVR) on amyloid imaging scans (18F-FBB PET) after lecanemab administration in the lecanemab adminstration group
次要结局
- longitudinal changes in the MMSE score(Change from baseline to 18 months)
- longituidnal changes in UPDRS-III scores.(Change from baseline to 18 months)
- Longitudinal changes in the plasma and cerebrospinal fluid biomarkers(Change from baseline to 18 months)
- longitudinal changes in the MoCA score.(Change from baseline to 18 months)
- longitudinal changes in CDR-SB.(Change from baseline to 18 months)
- longituidnal changes in composite scores of each cognitive domain.(Change from baseline to 18 months)
- longituidnal changes in levodopa-equivalent doses per body weight [mg/kg].(Change from baseline to 18 months)