Alexandra Fortunato , Alison O'Donnell , Brittany Spitznogle , Naveen Reddy , Shaye Kerper , Steven Handler
{"title":"83. SUPPORTING THE SAFETY OF ANTI-AMYLOID MONOCLONAL ANTIBODY THERAPY FOR EARLY ALZHEIMER'S DISEASE IN UNITED STATES VETERANS","authors":"Alexandra Fortunato , Alison O'Donnell , Brittany Spitznogle , Naveen Reddy , Shaye Kerper , Steven Handler","doi":"10.1016/j.jagp.2025.04.085","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Aging United States Military Veterans are at an increased risk of developing dementia compared to the general population due to both military and non-military-related risk factors. With the Food and Drug Administration (FDA) approval of lecanemab (Leqembi ®), a monoclonal antibody therapy (mAb) directed against amyloid beta, Veterans now have access to disease modifying treatment for Alzheimer’s Disease (AD). The implementation of this novel treatment at the VA has uncovered significant education gaps and safety challenges. Specifically, there was a lack of both Veteran and clinician-facing materials for implementation and monitoring lecanemab. Thus, a variety of materials were developed by this project's authors from January 4, 2024 through August 9, 2024 and were distributed via the national VA SharePoint site. Veteran-facing materials prioritized education and safety and included information about lecanemab and its potential adverse effects. A wallet card was also developed to highlight the need for emergent evaluation and MRI brain scan if certain side effects occurred. Clinician-facing documents focused on the potential adverse effects of lecanemab, Veteran inclusion/exclusion criteria, and diagnosis of AD. To better understand the impact that these new materials have had at a national level, we developed and distributed a survey to select VA healthcare professionals. The objective of this project was to perform a gap analysis, obtain broad feedback on currently available educational materials for lecanemab, and set priorities for the development and dissemination of additional materials to support the safe use of lecanemab within the VA.</div></div><div><h3>Methods</h3><div>We conducted a cross-sectional survey of healthcare professionals who actively participate in the national Veteran’s Health Administration (VHA) Novel AD Therapeutics Community of Practice (CoP) Workgroup. The survey was sent out on September 17, 2024 and remained open until October 4, 2024. The primary outcome was the awareness of existing lecanemab educational materials, as described above, among healthcare professionals in the CoP Workgroup involved in lecanemab implementation. Only lecanemab was evaluated since the second mAb, donanemab (Kisunla®) was not commercially available at the time of the study. Secondary outcomes focused on evaluating the effectiveness of resources necessary to: identify Veterans eligible for lecanemab, educate Veterans and caregivers on its use, determine the appropriate dosing schedule, establish monitoring protocols, and manage potential side effects effectively. Outcomes were measured using Microsoft Forms web-based survey software and were reported on a 5-point Likert scale, ranging from “strongly disagree” to “strongly agree”. The two positive responses (“agree” and “strongly agree”) and the two negative responses (“disagree” and “strongly disagree”) were combined to make positive and negative response groups, respectively. Qualitative feedback was also solicited about existing internal resources and the need for additional resources. This study was approved as a quality improvement project.</div></div><div><h3>Results</h3><div>An email containing a link to the survey was sent one time to 128 healthcare professionals with a 34% response rate (n=44). Of the responders, 59% were physicians (n=26), 25% were pharmacists (n=11), 5% were psychologists (n=2), 5% were nurses (n=2), 5% were program managers (n=2), and 2% declined to provide their role (n=1). In all, 41% (n=18) indicated that they were currently administering lecanemab, 32% (n=14) indicated that they were planning on administering lecanemab, 20% (n=9) indicated that they were unsure if they would be administering lecanemab, and 7% (n=3) indicated that they would not be offering the medication.</div><div>Forty-three percent of participants (n=19) indicated that they were unaware of existing educational materials about lecanemab. In terms of knowledge of lecanemab, 77% (n=34) indicated that they had the necessary resources to decide if lecanemab is right for a patient, 73% (n=32) felt they had the resources to determine the appropriate dosing schedule, 64% (n=28) felt they had the resources to determine monitoring requirements, and 64% (n=28) felt they had the resources to identify and guide management of side effects.</div></div><div><h3>Conclusions</h3><div>Our results demonstrate that healthcare professionals within the CoP Workgroup, many of whom have been involved in lecanemab implementation at their respective sites, were not aware of existing documents. Furthermore, these results identify a gap regarding effectiveness of available resources. Feedback from this survey will help guide further development and dissemination of educational materials regarding implementation, prescribing, and monitoring of lecanemab and other mAb as they become available, ultimately improving the quality and safety of Veteran care.</div></div>","PeriodicalId":55534,"journal":{"name":"American Journal of Geriatric Psychiatry","volume":"33 10","pages":"Page S61"},"PeriodicalIF":3.8000,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Geriatric Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1064748125001952","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction
Aging United States Military Veterans are at an increased risk of developing dementia compared to the general population due to both military and non-military-related risk factors. With the Food and Drug Administration (FDA) approval of lecanemab (Leqembi ®), a monoclonal antibody therapy (mAb) directed against amyloid beta, Veterans now have access to disease modifying treatment for Alzheimer’s Disease (AD). The implementation of this novel treatment at the VA has uncovered significant education gaps and safety challenges. Specifically, there was a lack of both Veteran and clinician-facing materials for implementation and monitoring lecanemab. Thus, a variety of materials were developed by this project's authors from January 4, 2024 through August 9, 2024 and were distributed via the national VA SharePoint site. Veteran-facing materials prioritized education and safety and included information about lecanemab and its potential adverse effects. A wallet card was also developed to highlight the need for emergent evaluation and MRI brain scan if certain side effects occurred. Clinician-facing documents focused on the potential adverse effects of lecanemab, Veteran inclusion/exclusion criteria, and diagnosis of AD. To better understand the impact that these new materials have had at a national level, we developed and distributed a survey to select VA healthcare professionals. The objective of this project was to perform a gap analysis, obtain broad feedback on currently available educational materials for lecanemab, and set priorities for the development and dissemination of additional materials to support the safe use of lecanemab within the VA.
Methods
We conducted a cross-sectional survey of healthcare professionals who actively participate in the national Veteran’s Health Administration (VHA) Novel AD Therapeutics Community of Practice (CoP) Workgroup. The survey was sent out on September 17, 2024 and remained open until October 4, 2024. The primary outcome was the awareness of existing lecanemab educational materials, as described above, among healthcare professionals in the CoP Workgroup involved in lecanemab implementation. Only lecanemab was evaluated since the second mAb, donanemab (Kisunla®) was not commercially available at the time of the study. Secondary outcomes focused on evaluating the effectiveness of resources necessary to: identify Veterans eligible for lecanemab, educate Veterans and caregivers on its use, determine the appropriate dosing schedule, establish monitoring protocols, and manage potential side effects effectively. Outcomes were measured using Microsoft Forms web-based survey software and were reported on a 5-point Likert scale, ranging from “strongly disagree” to “strongly agree”. The two positive responses (“agree” and “strongly agree”) and the two negative responses (“disagree” and “strongly disagree”) were combined to make positive and negative response groups, respectively. Qualitative feedback was also solicited about existing internal resources and the need for additional resources. This study was approved as a quality improvement project.
Results
An email containing a link to the survey was sent one time to 128 healthcare professionals with a 34% response rate (n=44). Of the responders, 59% were physicians (n=26), 25% were pharmacists (n=11), 5% were psychologists (n=2), 5% were nurses (n=2), 5% were program managers (n=2), and 2% declined to provide their role (n=1). In all, 41% (n=18) indicated that they were currently administering lecanemab, 32% (n=14) indicated that they were planning on administering lecanemab, 20% (n=9) indicated that they were unsure if they would be administering lecanemab, and 7% (n=3) indicated that they would not be offering the medication.
Forty-three percent of participants (n=19) indicated that they were unaware of existing educational materials about lecanemab. In terms of knowledge of lecanemab, 77% (n=34) indicated that they had the necessary resources to decide if lecanemab is right for a patient, 73% (n=32) felt they had the resources to determine the appropriate dosing schedule, 64% (n=28) felt they had the resources to determine monitoring requirements, and 64% (n=28) felt they had the resources to identify and guide management of side effects.
Conclusions
Our results demonstrate that healthcare professionals within the CoP Workgroup, many of whom have been involved in lecanemab implementation at their respective sites, were not aware of existing documents. Furthermore, these results identify a gap regarding effectiveness of available resources. Feedback from this survey will help guide further development and dissemination of educational materials regarding implementation, prescribing, and monitoring of lecanemab and other mAb as they become available, ultimately improving the quality and safety of Veteran care.
期刊介绍:
The American Journal of Geriatric Psychiatry is the leading source of information in the rapidly evolving field of geriatric psychiatry. This esteemed journal features peer-reviewed articles covering topics such as the diagnosis and classification of psychiatric disorders in older adults, epidemiological and biological correlates of mental health in the elderly, and psychopharmacology and other somatic treatments. Published twelve times a year, the journal serves as an authoritative resource for professionals in the field.