Feasibility of Lecanemab Registry and Clinical Outcome Measures

NCT06285448 | Enrolling By Invitation

• 1 other identifier: A24-028
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

lecanemab

Outcome Measures

Primary Outcomes (4)

• 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

• Feasibility of completing visits

  Number of enrolled participants completing the baseline and visit at 3 months.

  3 months

• Qualitative experience at 3 months

  Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .

  3 months

• Qualitative experience at 12 months

  Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews .

  12 months

Study Arms (1)

Patients with Alzheimer's disease

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

Drug: Lecanemab

Interventions

Lecanemab DRUG

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

Patients with Alzheimer's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PLWD who are eligible to receive Lecanemab at HealthPartners clinics as standard of care, referred by clinic staff and their care partners.

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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bhavani Kashyap, MBBS, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)