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Donanemab Exposure and Efficacy Relationship Using Modeling in Alzheimer's Disease

Alzheimer's and Dementia: Translational Research and Clinical Interventions, 2023
INTRODUCTION Donanemab is an amyloid‐targeting therapy that specifically targets brain amyloid plaques. The objective of these analyses was to characterize the relationship of donanemab exposure with plasma biomarkers and clinical efficacy through ...
Ivelina Gueorguieva, Brian Willis, Sergey Shcherbinin   +2 more
exaly   +2 more sources

Donanemab (LY3002813) Dose-Escalation Study in Alzheimer's Disease

Alzheimer's and Dementia: Translational Research and Clinical Interventions, 2021
Introduction This study explored the safety and tolerability features of donanemab (LY3002813) in patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild to moderate AD dementia.
Brian Willis, Paul Ardayfio, Sergey Shcherbinin   +2 more
exaly   +2 more sources

Experience with donanemab over a 1‐year period: observations of side effects and compliance from a regional specialty medical center [PDF]

Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring
INTRODUCTION The anti‐amyloid monoclonal antibody donanemab (Kisunla™) treats patients with mild cognitive impairment or mild Alzheimer's disease. METHODS This study highlights 51 patients who received at least one donanemab infusion at our memory center
Lisa B. E. Shields, Hannah S. Hust, Gregory E. Cooper, Theresa Kluthe, Rachel N. Hart, Andrew P. Thaliath, Brandon C. Dennis, Stephanie W. Freeman, Jessica F. Cain, Whoy Y. Shang, Kendall M. Wasz, Adam T. Orr, Christopher B. Shields, Shirish S. Barve, Kenneth G. Pugh   +14 more
doaj   +2 more sources

Real‐world evidence for amyloid‐targeted therapies: Lecanemab and donanemab [PDF]

Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring
INTRODUCTION Real‐world safety data on amyloid‐targeted therapies in early Alzheimer's disease remain limited, particularly for modified donanemab titration and direct lecanemab–donanemab comparisons.
Ryan Hakim, Kristofer Harris, Livia Merrill, Amanda Falk‐Vargas, Eileen Whalen, Tianxu Xia, Olga Ochoa, David Hunter, Paul Ernest Schulz   +8 more
doaj   +2 more sources

Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses [PDF]

The Journal of Prevention of Alzheimer's Disease
Background: In the European Union (EU), donanemab is indicated in adults with early symptomatic Alzheimer’s disease who are apolipoprotein E ε4 non-carriers or heterozygotes.
Frank Jessen, Grazia Dell’Agnello, Jennifer A. Zimmer, Christophe Sapin, Sascha Dichter, Erin Doty, Stéphane Epelbaum, Cynthia D. Evans, Paula M. Hauck, Rashna Khanna, Dawn A. Brooks, John R. Sims, Federica Agosta   +12 more
doaj   +2 more sources

Anti-Amyloid Monoclonal Antibodies in Early Alzheimer Disease: Lecanemab and Donanemab [PDF]

Neurology International
Background/Objectives: Alzheimer disease (AD) causes progressive cognitive and functional loss and substantial caregiver and healthcare burden. Anti-amyloid monoclonal antibodies represent a shift toward biology-directed treatment in biomarker-confirmed ...
Ülkü Figen Demir, Fatmanur Karakuş Dilbaz   +1 more
doaj   +2 more sources

Comparison of double-blind and open-label decline rates in lecanemab and donanemab trials in Alzheimer’s disease [PDF]

BMJ Neurology Open
Background Phase 3 trials of the anti-amyloid monoclonal antibodies lecanemab and donanemab in Alzheimer’s disease demonstrated modest slowing of cognitive decline over 18 months. Subsequent open-label extensions (OLE) suggested greater long-term benefit
Alberto J Espay, Alok K Dwivedi, Bruno P Imbimbo, Jesus Abanto   +3 more
doaj   +2 more sources

Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study [PDF]

Therapeutic Advances in Drug Safety
Background: Anti-β-amyloid monoclonal antibodies provide a disease-modifying treatment approach for Alzheimer’s disease, but post-marketing safety concerns remain, particularly amyloid-related imaging abnormalities (ARIA).
Wei-Yang Xue, Xi Li, Wen-Ting Li, Bao-Zhi Qin, Cong-Zhi Wang, Tao Liu, Min Wang   +6 more
doaj   +2 more sources

Donanemab Immunogenicity in Participants With Early Symptomatic Alzheimer's Disease

Alzheimer's and Dementia: Translational Research and Clinical Interventions
INTRODUCTION Donanemab is an immunoglobulin G1 antibody that targets an N‐terminal truncated form of amyloid beta present in mature plaques. Treatment‐emergent (TE) anti‐drug antibodies (ADAs) were quantified in donanemab‐treated participants from two ...
Jennifer A Zimmer, Cynthia D Evans, Paul Ardayfio   +2 more
exaly   +2 more sources

Analysis signals of disproportionate reporting associated with donanemab: A retrospective pharmacovigilance study using the FAERS database [PDF]

Science Progress
Objective This study aims to identify signals of disproportionate reporting (SDR) associated with donanemab by analyzing data from the Food and Drug Administration’s Adverse Event Reporting System (FAERS) database.
Yujian Zhang, Qineng Gong, Jin Yu, Linlin Zhang, Ye Hu   +4 more
doaj   +2 more sources