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临床试验/NCT06285448
NCT06285448Enrolling By Invitation不适用

Feasibility of Lecanemab Registry and Clinical Outcome Measures

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月2日最近更新:
适应症
干预措施
相关药物

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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