Feasibility of Lecanemab Registry and Clinical Outcome Measures

• Conditions: Alzheimer Disease
• Interventions: Drug: Lecanemab

• Registration Number: NCT06285448
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• Unable to read and speak English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Alzheimer's disease	Lecanemab	Patients with Alzheimer's disease eligible to receive lecanemab infusions at HealthPartners clinics and their care partners.

Primary Outcome Measures

Name	Time	Method
Feasibility of enrollment	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	3 months	Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .
Feasibility of completing visits	3 months	Number of enrolled participants completing the baseline and visit at 3 months.
Qualitative experience at 12 months	12 months	Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews .

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States