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| http://dx.doi.org/10.1007/s11606-024-08735-5 | DOI Listing |
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Drug Development.
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.
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Alzheimers Dement
December 2024
University of California San Francisco (UCSF), San Francisco, CA, USA; Northern California Institute for Research & Education (NCIRE), San Francisco, CA, USA; San Francisco Veterans Administration Medical Center (SFVAMC), San Francisco, CA, CA, USA.
The Alzheimer's Disease Neuroimaging Initiative (ADNI) has made many important contributions to the development of Alzheimer's Disease (AD) disease modifying treatments and diagnostic biomarkers. Since its funding in 2004 by the National Institutes of Aging, the goal of ADNI has been the validation of biomarkers for AD treatment trials. ADNI has enrolled over 2,400 participants in the USA and Canada for longitudinal clinical, cognitive, and biomarker studies.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Hospital de la Santa Creu i Sant Pau - Biomedical Research Institute Sant Pau - Autonomous University of Barcelona, Barcelona, Catalonia, Spain.
Background: Alzheimer's and related disorders (ADRD) represent a range of neurodegenerative conditions characterized by abnormal protein deposits in the brain. Despite advances, there is a need for enhanced diagnostic and treatment approaches that acknowledge the diversity of ADRD. This project introduces the Alzheimer's and Related Disorders Multicenter Archive (ARMA), a collaborative platform with an advanced Electronic Data Capture (EDC) system linked to Electronic Medical Records (EMR) designed to refine ADRD diagnosis and natural history understanding, thus informing precision medicine.
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Alzheimers Dement
December 2024
German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
Numerous drugs (including disease-modifying therapies, cognitive enhancers and neuropsychiatric treatments) are being developed for Alzheimer's and related dementias (ADRD). Emerging neuroimaging modalities, and genetic and other biomarkers potentially enhance diagnostic and prognostic accuracy. These advances need to be assessed in real-world studies (RWS).
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Alzheimers Dement
December 2024
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Background: Anti-amyloid immunotherapies modestly slow disease progression in early symptomatic AD; addition of other therapeutic modalities may be necessary to achieve larger treatment effects. Therapies that directly target tau can potentially produce substantial clinical benefit because the accumulation of insoluble tau protein is strongly correlated with the progression of AD. Which tau therapies are likely to be efficacious, whether or not to combine them with anti-amyloid therapies, and which individuals are most likely to benefit are important unresolved questions that would require multiple parallel design trials to answer.
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