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NCT06285448

Feasibility of Lecanemab Registry and Clinical Outcome Measures

ENROLLING BY INVITATION Last updated 28 January 2026
What this trial tests

trial testing Lecanemab in Alzheimer Disease in 20 participants. Enrolling by invitation.

Timeline
2 January 2024
Primary endpoint
31 December 2027
30 June 2028

Quick facts

Lead sponsorHealthPartners Institute
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment20
Start date2 January 2024
Primary completion31 December 2027
Estimated completion30 June 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

HealthPartners Institute

Who can join

18 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Molecular Mechanisms Underlying Alzheimer's Disease Pathogenesis: Comprehensive Overview.
    Lo Vecchio F, la Torre A, Gravina C, D'Onofrio G, et al · · 2026 · PMID 42196628 · DOI 10.3390/ijms27104651

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Other trials of Lecanemab

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other HealthPartners Institute trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing