Feasibility of Lecanemab Registry and Clinical Outcome Measures

Alzheimer Disease Clinical Trial

Official title:

Feasibility of Lecanemab Registry and Clinical Outcome Measures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06285448
• Other study ID #: A24-028
• Status: Enrolling by invitation
• Start date: January 2, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Lecanemab
Bi-weekly infusions of lecanemab [exposure].

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrollment	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.	2 years
Primary	Feasibility of completing visits	Number of enrolled participants completing the baseline and visit at 3 months.	3 months
Primary	Qualitative experience at 3 months	Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .	3 months
Primary	Qualitative experience at 12 months	Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews .	12 months