Feasibility of Lecanemab Registry and Clinical Outcome Measures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Alzheimer's disease

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

Lecanemab

Intervention Type DRUG

Bi-weekly infusions of lecanemab \[exposure\].

Interventions

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Lecanemab

Bi-weekly infusions of lecanemab \[exposure\].

Intervention Type DRUG

Eligibility Criteria

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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.