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Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer’s disease
BackgroundThis review describes the research and development process of gantenerumab, a fully human anti-amyloid monoclonal antibody in development...
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Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease
Immunotherapy against amyloid-beta (Aβ) is a promising option for the treatment of Alzheimer’s disease (AD). Aβ exists as various species, including...
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A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer’s disease
Dominantly inherited Alzheimer’s disease (DIAD) causes predictable biological changes decades before the onset of clinical symptoms, enabling testing...
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Aducanumab, gantenerumab, BAN2401, and ALZ-801—the first wave of amyloid-targeting drugs for Alzheimer’s disease with potential for near term approval
The body of evidence suggesting a causative, initiating role of beta amyloid (Aβ) in the pathogenesis of Alzheimer’s disease (AD) is substantial....
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Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer’s disease: a PET substudy interim analysis
BackgroundWe previously investigated low doses (105 or 225 mg) of gantenerumab, a fully human monoclonal antibody that binds and removes aggregated...
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Passive immunotherapy for Alzheimer’s disease: challenges & future directions
Passive immunotherapy with specific antibodies targeting Amyloid β (Aβ) peptide or tubulin-associated unit (tau) protein has emerged as a promising...
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Learnings about Aβ from human brain recommend the use of a live-neuron bioassay for the discovery of next generation Alzheimer’s disease immunotherapeutics
Despite ongoing debate, the amyloid β-protein (Aβ) remains the prime therapeutic target for the treatment of Alzheimer’s disease (AD). However,...
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Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies
This article evaluates the performance of pharmacokinetic (PK) equivalence testing between two formulations of a drug through the Two-One Sided Tests...
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The Amyloid Cascade Hypothesis Has to Deliver, Finally
The Alzheimer’s field has been intensively searching for a therapy, especially in the last 30 years, while the number of affected individuals has...
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Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer’s Disease
Two monoclonal antibodies (mAbs), aducanumab and lecanemab, have received accelerated approval from the US FDA for initiation of treatment in early...
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Optimization of therapeutic antibodies for reduced self-association and non-specific binding via interpretable machine learning
Antibody development, delivery, and efficacy are influenced by antibody-antigen affinity interactions, off-target interactions that reduce antibody...
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“If You Change the Way You Look at Things, Things You Look at Change”
The exact causes of Alzheimer’s disease are still largely elusive and under dispute. The focus on amyloid beta as the central trigger of the disease...
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Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm
AbstractThe standard errors (SE) of the maximum likelihood estimates (MLE) of the population parameter vector in nonlinear mixed effect models...
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Utilization of fluid-based biomarkers as endpoints in disease-modifying clinical trials for Alzheimer’s disease: a systematic review
BackgroundClinical trials in Alzheimer’s disease (AD) had high failure rates for several reasons, including the lack of biological endpoints....
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Anti-Amyloid Immunotherapies for Alzheimer’s Disease: A 2023 Clinical Update
The amyloid cascade hypothesis is a useful framework for therapeutic development in Alzheimer’s disease (AD). Amyloid b 1-42 (Aβ) has been the main...
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Aβ42 oligomer-specific antibody ALZ-201 reduces the neurotoxicity of Alzheimer’s disease brain extracts
BackgroundIn Alzheimer’s disease (AD), amyloid-β 1–42 (Aβ42) neurotoxicity stems mostly from its soluble oligomeric aggregates. Studies of such...
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Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update
Alzheimer's disease (AD) is the leading cause of dementia, presenting a significant unmet medical need worldwide. The pathogenesis of AD involves...
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Commentaries: Lecanemab: pioneering the way as the first approved drug for Alzheimer’s disease treatment
Alzheimer's disease (AD) is a progressive neurodegenerative disorder marked by cognitive decline and neuronal abnormalities. Current therapies...
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Is the Persistence of the Amyloid Cascade Hypothesis a Result of Constant Confirmation Bias?
Whenever a hypothesis has been around for a very long time, chances are that it has a constantly growing number of followers and a diminishing number...
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Pathophysiology and Management Approaches in Alzheimer’s Disease
Alzheimer’s disease is recognized as a progressive multifarious neurodegenerative disorder that is pathologically characterized by the deposition of...