NCT06285448Enrolling by invitation
Feasibility of Lecanemab Registry and Clinical Outcome Measures
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 2 Jan 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- HealthPartners Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT06285448
What you commit to
- Study type: Observational
- Planned participants: 20
- From 2 Jan 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to read and speak English
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HealthPartners Neuroscience Center Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.