ArticleAlzheimer's & dementia (New York, N. Y.)
Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease.
Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Brain Amyloid Plaque Levels Affect Clinical Progression in Alzheimer Disease: Assessment of Amyloid PET and Change in CDR-SB Utilizing Semi-Mechanistic Model.CPT: pharmacometrics & systems pharmacology · 2026Trial
- Donanemab exposure-response in early symptomatic Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- A new amyloid PET evaluation method using separated gray-matter histogram based on three-component model.Annals of nuclear medicine · 2026Article
- Clinical Validation of Novel Immunoassays for Plasma Phosphorylated Tau 217, 212, 181, 231, and Brain-Derived Tau Across the Biochemical Spectrum of Alzheimer's Disease.Journal of neurochemistry · 2025Article
- Impact of O-GlcNAcylation Elevation on Mitophagy and Glia in the Dentate Gyrus.Journal of neurochemistry · 2025Article
- Profiling RNA Cargo in Extracellular Vesicles From hiPSC-Derived Neurons of Alzheimer's Disease Patients.Journal of extracellular biology · 2025Article
- Translational Medicine in Alzheimer's Disease: The Journey of Donanemab From Discovery to Clinical Application.Chronic diseases and translational medicine · 2025Review
- Rock inhibitors in Alzheimer's disease.Frontiers in aging · 2025Review
- The Taiwan-ADNI workflow toward integrating plasma p-tau217 into prediction models for the risk of Alzheimer's disease and tau burden.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Article
- Identification of isoAsp7-Aβ as a major Aβ variant in Alzheimer's disease, dementia with Lewy bodies and vascular dementia.Acta neuropathologica · 2024Article
- Clinical Meaningfulness in Alzheimer's Disease Clinical Trials. A Report from the EU-US CTAD Task Force.The journal of prevention of Alzheimer's disease · 2024Article
- A case for seeking sex-specific treatments in Alzheimer's disease.Frontiers in aging neuroscience · 2024Review
- ROCK Inhibitor Fasudil Attenuates Neuroinflammation and Associated Metabolic Dysregulation in the Tau Transgenic Mouse Model of Alzheimer's Disease.Current Alzheimer research · 2024Article
- Translating NIA-AA criteria into usual practice: Report from the ReDeMa Project.Alzheimer's & dementia (New York, N. Y.)Article
- Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease.Alzheimer's & dementia (New York, N. Y.)Article
- Pharmacokinetic/pharmacodynamic analyses of plasma pathophysiology biomarkers in subjects with early Alzheimer's disease following lecanemab treatment.Alzheimer's & dementia (New York, N. Y.)Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDonanemab 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 modeling.
methodsData for the analyses were from participants with Alzheimer's disease from the phase 1 and TRAILBLAZER-ALZ studies. Indirect-response models were used to fit plasma phosphorylated tau 217 (p-tau217) and plasma glial fibrillated acidic protein (GFAP) data over time. Disease-progression models were developed using pharmacokinetic/pharmacodynamic modeling.
resultsThe plasma p-tau217 and plasma GFAP models adequately predicted the change over time, with donanemab resulting in decreased plasma p-tau217 and plasma GFAP concentrations. The disease-progression models confirmed that donanemab significantly reduced the rate of clinical decline. Simulations revealed that donanemab slowed disease progression irrespective of baseline tau positron emission tomography (PET) level within the evaluated population. DISCUSSION: The disease-progression models show a clear treatment effect of donanemab on clinical efficacy regardless of baseline disease severity.
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