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. 2024 Nov;20(11):8162-8171.
doi: 10.1002/alz.14199. Epub 2024 Sep 22.

Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer's disease: Navigating clinician-patient engagement

Dorene M Rentz  1 , Paul S Aisen  2 , Alireza Atri  3 , Janice Hitchcock  4 , Michael Irizarry  5 , Jaren Landen  6 , Brandy R Matthews  7 , David S Miller  8 , Simin Mahinrad  9 , Salvatore Napoli  10 , Hamid R Okhravi  11 , Ronald C Petersen  12 , Eric R Siemers  4 , Christopher J Weber  9 , David C Weisman  13 , Maria C Carrillo  9
Affiliations

Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer's disease: Navigating clinician-patient engagement

Dorene M Rentz et al. Alzheimers Dement. 2024 Nov.

Abstract

The emergence of the United States Food and Drug Administration (FDA)-approved amyloid-targeting therapies for Alzheimer's disease challenges clinicians and healthcare providers with a transformative landscape. Effectively communicating the risks, benefits, burdens, costs, and available support associated with these novel disease-modifying treatments to patients, families, and other healthcare providers is essential but complex. In response, the Alzheimer's Association's Clinical Meaningfulness Workgroup has proposed language surrounding treatment eligibility, benefits, amyloid-related imaging abnormalities (ARIA), apolipoprotein E (APOE) genotyping, and treatment costs, serving as a resource to healthcare professionals in navigating discussions with patients and their families. As the landscape evolves with the approval of new Alzheimer's therapies, this resource stands poised for updates, ensuring its continued relevance in facilitating informed and meaningful patient-provider dialogues. HIGHLIGHTS: Effective communication of risks, benefits, burdens, and costs of FDA-approved amyloid-targeting antibodies is essential to patients, families, and healthcare providers. The Alzheimer's Association's Clinical Meaningfulness Workgroup provides language for physicians and healthcare providers around treatment eligibility, benefits, ARIA, APOE genotyping, and treatment costs. This supplementary resource may be updated as new AD therapies become approved.

Keywords: Alzheimer's disease; amyloid targeting therapies; anti‐amyloid therapies; benefit; clinical meaningfulness; patient; patient‐care dyad; risk; treatment.

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Conflict of interest statement

A.A. has received honoraria or support for consulting; participating in independent data safety monitoring boards; providing educational lectures, programs, and materials; or serving on advisory or oversight boards for AbbVie, Acadia, Allergan, the Alzheimer's Association, Alzheimer's Disease International, Axovant, AZ Therapies, Biogen, Eisai, Grifols, Harvard Medical School Graduate Continuing Education, JOMDD, Life Molecular Imaging, Lundbeck, Merck, Prothena, Roche/Genentech, Novo Nordisk, Qynapse, Sunovion, Suven, and Synexus. A.A. receives book royalties from Oxford University Press for a medical book on dementia. A.A. receives institutional research grant/contract funding from NIA/NIH 1P30AG072980, NIA/NIH U22AG057437, AZ DHS CTR040636, Washington University St Louis, and Gates Ventures. A.A.’s institution receives/received funding for clinical trial grants, contracts and projects from government, consortia, foundations and companies for which he serves/served as contracted site‐PI. Of special note, A.A. currently serves as site‐PI for the AHEAD 3‐45 study (lecanemab for secondary AD prevention); and previously served as site‐PI for the A4 study (solanezumab for secondary AD prevention), as site‐PI (at his previous institution) for the Biogen EMERGE study (aducanumab for early‐AD treatment), and as Project Arm Leader for the DIAN‐TU Gantenerumab study. PSA has received grants or contracts to support research from the NIH, Alzheimer's Association, FNIH, Lilly, Janssen, and Eisai, and has received consultant fees from Merck, Biogen, Abbvie, Roche, Immunobrain Checkpoint. D.S.M. is a full‐time employee and shareholder of Signant Health. RCP is a full‐time employee of Mayo Foundation for Education and Research, a consultant for Roche, Inc., Nestle, Eli Lilly & Co., Genentech Inc. (including DSMB), and Eisai, Inc., and has received grant funding from NIA ADRC, MCSA, ADNI, ACTC, MarkVCID. D.M.R. has received consulting fees from the Dana Foundation. S.M., C.J.W. and M.C.C. are full‐time employees of the Alzheimer's Association. J.H. is a full‐time employee of Acumen, has received consulting fees from Washington University Dominantly Inherited Alzheimer Network Trials Unit (DIAN‐TU), and is a stockholder for Acumen and Eli Lilly. E.R.S. is full‐time employees of Acumen, and has received consulting fees from Cogstate Ltd., Cortexyme Inc., Partner Therapeutics Inc., Vaccinex Inc., Gates Ventures LLC, Hoffman La Roche Ltd, US Green Valley Pharmaceuticals Inc., has participated on a DMSB for Hoffman La Roche Ltd, has been an unpaid consultant and unpaid board of directors member for the Alzheimer's Association and Bright Focus Foundation, respectively, and is a stockholder for Acumen and Eli Lilly. M.I. is a full‐time employee of Eisai, Inc. J.L. was a full‐time employee of Biogen and Biogen stockholder at the time of manuscript creation/submission. B.R.M. is a full‐time employee and shareholder of Eli Lilly & Co. SN has received payment or honoraria from Eisai, Biogen, Serono, and TG Therapeutics. HO has received compensation from Biogen & Eisai (salary support), and Biogen & Optina Diagnostics (consulting fees to Eastern Virginia Medical School). D.C.W. has received grants or contracts from ATRI, Eisai, ATRI, Cognition, Acumen, Cerevel, Sage, Acadia, Alzheimer's Association, Alzheon, Lilly, Roche, Serono, Sanofi, received payment or honoraria from AAN, Eisai, and Lilly, and has participated in DSMBs for Biogen, Eisai, Novartis, FDA, Maplight, and VizAI. Author disclosures are available in the Supporting Information.

Figures

FIGURE 1
FIGURE 1
Illustration of “time saved,” adapted from Petersen et al.
See this image and copyright information in PMC

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