NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Lecanemab	Bi-weekly infusions of lecanemab \[exposure\].

Timeline

• Start date: 2024-01-02
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-02-29
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States