Feasibility of Lecanemab Registry and Clinical Outcome Measures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of enrollment
研究概览
简要总结
Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PLWD who are eligible to receive Lecanemab infusion at our clinics.
- •Care Partner who provides care for the PLWD who are eligible to receive Lecanemab infusion at our clinics.
- •Age >=18 years for PLWD and their care partners
- •Provides informed consent prior to participation.
排除标准
- •Unable to read and speak English
研究组 & 干预措施
Patients with Alzheimer's disease
Patients with Alzheimer's disease eligible to receive lecanemab infusions at HealthPartners clinics and their care partners.
干预措施: Lecanemab (Drug)
结局指标
主要结局
Feasibility of enrollment
时间窗: 2 years
Absolute number of potential care dyads (care partners and people living with dementia) contacted for recruitment and the number of those who consent and enroll.
Qualitative experience at 3 months
时间窗: 3 months
Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .
Feasibility of completing visits
时间窗: 3 months
Number of enrolled participants completing the baseline and visit at 3 months.
Qualitative experience at 12 months
时间窗: 12 months
Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews .
次要结局
未报告次要终点
