AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial

Abstract Alzheimer’s Disease (AD) drug discovery has been hampered by patient heterogeneity, and the lack of sensitive tools for precise stratification. Here, we demonstrate that our robust and interpretable AI-guided tool (predictive prognostic model, PPM) enhances precision in patient stratificati...

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Main Authors: Delshad Vaghari, Gayathri Mohankumar, Keith Tan, Andrew Lowe, Craig Shering, Peter Tino, Zoe Kourtzi
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-61355-3
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author Delshad Vaghari
Gayathri Mohankumar
Keith Tan
Andrew Lowe
Craig Shering
Peter Tino
Zoe Kourtzi
author_facet Delshad Vaghari
Gayathri Mohankumar
Keith Tan
Andrew Lowe
Craig Shering
Peter Tino
Zoe Kourtzi
author_sort Delshad Vaghari
collection DOAJ
description Abstract Alzheimer’s Disease (AD) drug discovery has been hampered by patient heterogeneity, and the lack of sensitive tools for precise stratification. Here, we demonstrate that our robust and interpretable AI-guided tool (predictive prognostic model, PPM) enhances precision in patient stratification, improving outcomes and decreasing sample size for a AD clinical trial. The AMARANTH trial of lanabecestat, a BACE1 inhibitor, was deemed futile, as treatment did not change cognitive outcomes, despite reducing β-amyloid. Employing the PPM, we re-stratify patients precisely using baseline data and demonstrate significant treatment effects; that is, 46% slowing of cognitive decline for slow progressive patients at earlier stages of neurodegeneration. In contrast, rapid progressive patients did not show significant change in cognitive outcomes. Our results provide evidence for AI-guided patient stratification that is more precise than standard patient selection approaches (e.g. β-amyloid positivity) and has strong potential to enhance efficiency and efficacy of future AD trials.
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spelling doaj-art-a1441c0fb36c4cab95a8d33c17b25df82025-08-20T04:03:02ZengNature PortfolioNature Communications2041-17232025-07-0116111210.1038/s41467-025-61355-3AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trialDelshad Vaghari0Gayathri Mohankumar1Keith Tan2Andrew Lowe3Craig Shering4Peter Tino5Zoe Kourtzi6Department of Psychology, University of CambridgeCentre for AI, Data Science & Artificial Intelligence, BioPharmaceuticals R&D, AstraZenecaNeuroscience, BioPharmaceuticals R&D, AstraZenecaNeuroscience, BioPharmaceuticals R&D, AstraZenecaNeuroscience, BioPharmaceuticals R&D, AstraZenecaSchool of Computer Science, University of BirminghamDepartment of Psychology, University of CambridgeAbstract Alzheimer’s Disease (AD) drug discovery has been hampered by patient heterogeneity, and the lack of sensitive tools for precise stratification. Here, we demonstrate that our robust and interpretable AI-guided tool (predictive prognostic model, PPM) enhances precision in patient stratification, improving outcomes and decreasing sample size for a AD clinical trial. The AMARANTH trial of lanabecestat, a BACE1 inhibitor, was deemed futile, as treatment did not change cognitive outcomes, despite reducing β-amyloid. Employing the PPM, we re-stratify patients precisely using baseline data and demonstrate significant treatment effects; that is, 46% slowing of cognitive decline for slow progressive patients at earlier stages of neurodegeneration. In contrast, rapid progressive patients did not show significant change in cognitive outcomes. Our results provide evidence for AI-guided patient stratification that is more precise than standard patient selection approaches (e.g. β-amyloid positivity) and has strong potential to enhance efficiency and efficacy of future AD trials.https://doi.org/10.1038/s41467-025-61355-3
spellingShingle Delshad Vaghari
Gayathri Mohankumar
Keith Tan
Andrew Lowe
Craig Shering
Peter Tino
Zoe Kourtzi
AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
Nature Communications
title AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
title_full AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
title_fullStr AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
title_full_unstemmed AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
title_short AI-guided patient stratification improves outcomes and efficiency in the AMARANTH Alzheimer’s Disease clinical trial
title_sort ai guided patient stratification improves outcomes and efficiency in the amaranth alzheimer s disease clinical trial
url https://doi.org/10.1038/s41467-025-61355-3
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