Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities
Alzheimer’s disease (AD) and other neurodegenerative diseases such as Parkinson’s disease (PD) and Huntington’s disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. St...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-06-01
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| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1210974/full |
| _version_ | 1797794994818383872 |
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| author | Anna-Katharine Brem Anna-Katharine Brem Sajini Kuruppu Casper de Boer Casper de Boer Marijn Muurling Marijn Muurling Ana Diaz-Ponce Dianne Gove Jelena Curcic Andrea Pilotto Andrea Pilotto Andrea Pilotto Wan-Fai Ng Wan-Fai Ng Nicholas Cummins Kristina Malzbender Vera J. M. Nies Gul Erdemli Johanna Graeber Vaibhav A. Narayan Lynn Rochester Lynn Rochester Walter Maetzler Dag Aarsland Dag Aarsland |
| author_facet | Anna-Katharine Brem Anna-Katharine Brem Sajini Kuruppu Casper de Boer Casper de Boer Marijn Muurling Marijn Muurling Ana Diaz-Ponce Dianne Gove Jelena Curcic Andrea Pilotto Andrea Pilotto Andrea Pilotto Wan-Fai Ng Wan-Fai Ng Nicholas Cummins Kristina Malzbender Vera J. M. Nies Gul Erdemli Johanna Graeber Vaibhav A. Narayan Lynn Rochester Lynn Rochester Walter Maetzler Dag Aarsland Dag Aarsland |
| author_sort | Anna-Katharine Brem |
| collection | DOAJ |
| description | Alzheimer’s disease (AD) and other neurodegenerative diseases such as Parkinson’s disease (PD) and Huntington’s disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse—Alzheimer’s disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (1) the value of remote technologies to assess neurodegenerative diseases; (2) feasibility, acceptability and usability of digital assessments; (3) challenges related to the use of digital tools; (4) public involvement and the implementation of patient advisory boards; (5) regulatory learnings; and (6) the significance of inter-project exchange and data- and algorithm-sharing. |
| first_indexed | 2024-03-13T03:11:10Z |
| format | Article |
| id | doaj.art-b25bfe9c3dfc482dab530af81d87e77c |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-03-13T03:11:10Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-b25bfe9c3dfc482dab530af81d87e77c2023-06-26T12:16:59ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-06-011410.3389/fneur.2023.12109741210974Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunitiesAnna-Katharine Brem0Anna-Katharine Brem1Sajini Kuruppu2Casper de Boer3Casper de Boer4Marijn Muurling5Marijn Muurling6Ana Diaz-Ponce7Dianne Gove8Jelena Curcic9Andrea Pilotto10Andrea Pilotto11Andrea Pilotto12Wan-Fai Ng13Wan-Fai Ng14Nicholas Cummins15Kristina Malzbender16Vera J. M. Nies17Gul Erdemli18Johanna Graeber19Vaibhav A. Narayan20Lynn Rochester21Lynn Rochester22Walter Maetzler23Dag Aarsland24Dag Aarsland25Department of Old Age Psychiatry, King’s College London, Institute of Psychiatry, Psychology and Neuroscience, London, United KingdomUniversity Hospital of Old Age Psychiatry, University of Bern, Bern, SwitzerlandDepartment of Old Age Psychiatry, King’s College London, Institute of Psychiatry, Psychology and Neuroscience, London, United KingdomAlzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmc, Amsterdam, NetherlandsAmsterdam Neuroscience, Neurodegeneration, Amsterdam, NetherlandsAlzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC Location VUmc, Amsterdam, NetherlandsAmsterdam Neuroscience, Neurodegeneration, Amsterdam, NetherlandsAlzheimer Europe, Luxembourg, LuxembourgAlzheimer Europe, Luxembourg, LuxembourgNovartis Institutes for Biomedical Research (NIBR), Basel, SwitzerlandNeurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, ItalyLaboratory of Digital Neurology and Biosensors, University of Brescia, Brescia, ItalyNeurology Unit, Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy0Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom1NIHR Newcastle Biomedical Research Centre and Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom2Department of Biostats and Health Informatics, King’s College London, Institute of Psychiatry, Psychology and Neuroscience, London, United Kingdom3Gates Ventures, Kirkland, WA, United States4Foundation Lygature, Utrecht, Netherlands5Novartis Pharmaceuticals Corporations, Cambridge, MA, United States6Institute of General Practice, University Medical Center Schleswig-Holstein, Kiel University, Kiel, Germany7Davos Alzheimer’s Collaborative, Geneva, Switzerland8Faculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom9National Institute for Health and Care Research (NIHR) Newcastle Biomedical Research Centre (BRC), Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom0Department of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, GermanyDepartment of Old Age Psychiatry, King’s College London, Institute of Psychiatry, Psychology and Neuroscience, London, United Kingdom1Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, NorwayAlzheimer’s disease (AD) and other neurodegenerative diseases such as Parkinson’s disease (PD) and Huntington’s disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse—Alzheimer’s disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (1) the value of remote technologies to assess neurodegenerative diseases; (2) feasibility, acceptability and usability of digital assessments; (3) challenges related to the use of digital tools; (4) public involvement and the implementation of patient advisory boards; (5) regulatory learnings; and (6) the significance of inter-project exchange and data- and algorithm-sharing.https://www.frontiersin.org/articles/10.3389/fneur.2023.1210974/fullAlzheimer’s diseaseParkinson’s diseaseHuntington’s diseaseneurodegenerative diseasesdementiadigital biomarker |
| spellingShingle | Anna-Katharine Brem Anna-Katharine Brem Sajini Kuruppu Casper de Boer Casper de Boer Marijn Muurling Marijn Muurling Ana Diaz-Ponce Dianne Gove Jelena Curcic Andrea Pilotto Andrea Pilotto Andrea Pilotto Wan-Fai Ng Wan-Fai Ng Nicholas Cummins Kristina Malzbender Vera J. M. Nies Gul Erdemli Johanna Graeber Vaibhav A. Narayan Lynn Rochester Lynn Rochester Walter Maetzler Dag Aarsland Dag Aarsland Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities Frontiers in Neurology Alzheimer’s disease Parkinson’s disease Huntington’s disease neurodegenerative diseases dementia digital biomarker |
| title | Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities |
| title_full | Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities |
| title_fullStr | Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities |
| title_full_unstemmed | Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities |
| title_short | Digital endpoints in clinical trials of Alzheimer’s disease and other neurodegenerative diseases: challenges and opportunities |
| title_sort | digital endpoints in clinical trials of alzheimer s disease and other neurodegenerative diseases challenges and opportunities |
| topic | Alzheimer’s disease Parkinson’s disease Huntington’s disease neurodegenerative diseases dementia digital biomarker |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1210974/full |
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