Feasibility of Lecanemab Registry and Clinical Outcome Measures

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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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lecanemab

Drug

Bi-weekly infusions of lecanemab [exposure].

Primary outcomes

Feasibility of enrollment

Time frame: 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.
Feasibility of completing visits

Time frame: 3 months

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

Time frame: 3 months

Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews .
Qualitative experience at 12 months

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2028
First posted: Feb 29, 2024
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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