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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Alzheimer's disease | Patients with Alzheimer's disease eligible to receive lecanemab infusions at HealthPartners clinics and their care partners. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lecanemab | Drug | Bi-weekly infusions of lecanemab [exposure]. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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PLWD who are eligible to receive Lecanemab at HealthPartners clinics as standard of care, referred by clinic staff and their care partners.
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| Name | Affiliation | Role |
|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000612089 | lecanemab |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |