Feasibility of Lecanemab Registry and Clinical Outcome Measures

Enrolling by invitation

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06285448

Run by

HealthPartners Institute

People needed

20

Starts

2024-01-02

Expected to finish

2028-06-30

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Unable to read and speak English

Where it is running

• HealthPartners Neuroscience Center — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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