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http://dx.doi.org/10.1039/an9861101341 | DOI Listing |
Background: Selecting the optimal dose for clinical development is especially problematic for drugs directed at CNS-specific targets. For drugs with a novel mechanism of action, these problems are often greater. We describe Xanamem's clinical pharmacology, including the approach to dose selection and proof-of-concept studies.
View Article and Find Full Text PDFBackground: Although investment in biomedical and pharmaceutical research has increased significantly over the past two decades, there are no oral disease-modifying treatments for Alzheimer's disease (AD).
Method: We performed comprehensive human genetic and multi-omics data analyses to test likely causal relationship between EPHX2 (encoding soluble epoxide hydrolase [sEH]) and risk of AD. Next, we tested the effect of the oral administration of EC5026 (a first-in-class, picomolar sEH inhibitor) in a transgenic mouse model of AD-5xFAD and mechanistic pathways of EC5026 in patient induced Pluripotent Stem Cells (iPSC) derived neurons.
Alzheimers Dement
December 2024
Critical Path for Alzheimer's Disease (CPAD) Consortium, Critical Path institute, Tucson, AZ, USA.
Background: To help improve the Alzheimer's disease (AD) therapeutics research and development process, the Critical Path for Alzheimer's Disease (CPAD) Consortium at the Critical Path Institute (C-Path) provides a neutral framework for the drug development industry, regulatory agencies, academia, and patient advocacy organizations to collaborate. CPAD's extensive track record of developing regulatory-grade quantitative drug development tools motivates sponsors to share patient-level data and neuroimages from clinical trials. CPAD leverages these data and uses C-Path's core competencies in data management and standardization, quantitative modeling, and regulatory science to develop tools that help de-risk decision making in AD drug development.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Australia, Melbourne, VIC, Australia.
Background: Iron is vital for metabolism but can act as a catalyst for oxidative damage. Elevated brain iron, determined from biomarkers of iron (CSF ferritin and quantitative susceptibility mapping MRI) and from post-mortem measurement of brain iron, has been associated with accelerated cognitive decline in multiple Alzheimer's disease (AD) clinical, cohorts. These findings supported the hypothesis that treatment with the brain-permeable iron chelator deferiprone may be associated clinical benefit in AD.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Kyunghee University Hospital at Gangdong, Seoul, Korea, Republic of (South).
Background: Recent preclinical studies have revealed a significant reduction in amyloid-β plaques and pro-inflammatory cytokines in Alzheimer's disease (AD) mouse models following low-dose radiation therapy (LDRT). This phase II, multicenter, prospective, single-blinded, randomized controlled trial (NCT05635968, funding from Korea Hydro & Nuclear Power: Grant No. A21IP11) aims to investigate the efficacy and safety of whole-brain LDRT in patients with AD.
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