Feasibility of Lecanemab Registry and Clinical Outcome Measures

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06285448
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lecanemab — DRUG
    Bi-weekly infusions of lecanemab \[exposure\].

Study Details

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.

Key Dates

Start date
Jan 2, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

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

Primary Outcome Measure

Feasibility of enrollment [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Neuroscience CenterSaint PaulMinnesota55130-

Find similar trials in Saint Paul, MN

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
HealthPartners Neuroscience Center· Saint Paul, MN

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