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 n...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-01-02
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-03-01
• 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.

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Exclusion Criteria

• Unable to read and speak English

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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