Results 1 to 10 of about 2,741 (139)

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.
Stephen Loucian Lowe, Brian A. Willis, Anne Hawdon, Fanni Natanegara, Laiyi Chua, Joanne Foster, Sergey Shcherbinin, Paul Ardayfio, John R. Sims   +8 more
exaly   +2 more sources

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 A. Willis, Laiyi Chua, Kay Chow, C. Steven Ernest II, Jian Wang, Sergey Shcherbinin, John R. Sims, Emmanuel Chigutsa   +8 more
exaly   +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

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

Donanemab: Appropriate use recommendations

journal of prevention of Alzheimer's disease, The
Donanemab (Kisunla®), an IgG1 monoclonal antibody targeting N-terminal pyroglutamate-modified forms of amyloid-β, is approved in the United States for treatment of early symptomatic Alzheimer's disease (AD). Appropriate Use Recommendations (AUR) were developed to guide the implementation of donanemab in real-world practice, prioritizing safety ...
Dennis J Selkoe, Suzanne Hendrix, Stephen Salloway   +2 more
exaly   +4 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

Real-world anti-amyloid therapy beyond traditional symptomatic populations: a longitudinal case series [PDF]

Frontiers in Psychiatry
IntroductionAnti-amyloid monoclonal antibodies are approved as disease-modifying therapies for early Alzheimer’s disease (AD), but real-world evidence remains limited, particularly among individuals treated during preclinical or minimally symptomatic ...
Jayoung Han, Yuan Fang, Darlingtina Esiaka, Olufunmilola Abraham   +3 more
doaj   +2 more sources

Comparison of safety of lecanemab and donanemab: a real-world disproportionality analysis using the FDA adverse event reporting system [PDF]

Frontiers in Pharmacology
BackgroundLecanemab and donanemab are anti-amyloid-β (Aβ) monoclonal antibodies recently approved for the treatment of Alzheimer’s disease (AD). Although both agents have demonstrated therapeutic potential, their post-marketing adverse event reporting ...
Xiuping Feng, Xiuping Feng, Shangqing Bi, Shangqing Bi, Chaoqiong Shi, Chaoqiong Shi, Qingqing Chang, Qingqing Chang, Jiaming Zhang, Jiaming Zhang, Yiyang Zhuang, Yiyang Zhuang   +11 more
doaj   +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

Targeting Amyloid Pathology in Early Alzheimer’s: The Promise of Donanemab-Azbt

Pharmacy (Basel, Switzerland)
Objective: The purpose of this review is to examine the potential role of donanemab-azbt in the treatment and management of early-stage Alzheimer’s disease (AD), with a focus on its efficacy, safety, and clinical relevance based on data from key clinical
Nadia Khartabil
exaly   +3 more sources