Feasibility of Lecanemab Registry and Clinical Outcome Measures - Trial NCT06285448

Timeline & Enrollment

Primary Outcome

Feasibility of enrollment,Feasibility of completing visits,Qualitative experience at 3 months,Qualitative experience at 12 months

Summary

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.

ICD-10 Classifications