Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285448
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-01
First Post:
2024-02-22
Brief Title:
Feasibility of Lecanemab Registry and Clinical Outcome Measures
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Feasibility of Lecanemab Registry and Clinical Outcome Measures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Available FDA approved treatments for Alzheimers 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 increasereduce 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 registrydatabase 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None