Alzheimer Disease
Conditions
Keywords
lecanemab
Brief summary
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.
Interventions
DRUGLecanemab
Bi-weekly infusions of lecanemab \[exposure\].
Sponsors
HealthPartners Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of enrollment | 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 | 3 months | Number of enrolled participants completing the baseline and visit at 3 months. |
| Qualitative experience at 3 months | 3 months | Summary of qualitative experience with lecanemab infusions at 3 months through survey and interviews . |
| Qualitative experience at 12 months | 12 months | Summary of qualitative experience with lecanemab infusions at 12 months through survey and interviews . |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBhavani Kashyap, MBBS, PhD
HealthPartners Institute
Outcome results
None listed