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EU funding (€21M): Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities in daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases Hor1 Nov 2019 EU Research and Innovation programme "Horizon"
Overview
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Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities in daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases
Fatigue and sleep disturbances are two common and disabling symptoms that affect patients with neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID). These symptoms are major predictors of poor quality of life and increased healthcare cost. Current questionnaire-based approaches to measure these symptoms have key limitations preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies. IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue and sleep disturbances that will provide more objective, sensitive and reliable measures of the severity and impact of these symptoms in ecological settings. Such digital endpoints will not only help to gain insight into the underpinning mechanisms of fatigue and sleep disturbances, but will also vastly improve the efficiency of clinical trials, ultimately reducing the time and cost to bring new therapies to patients. To identify these digital endpoints, we will follow the recommendations of the Clinical Trials Transformation Initiative (CTTI). We will identify the characteristics that fatigue and sleep disturbances will have impact, then select the digital measures (endpoints) to quantify them, followed by choosing the appropriate digital device/technology accordingly. We will then perform a pilot study to prioritise a few of these candidate digital endpoints for validation. We will test the performance of these digital endpoints in two NDD and four IMID in a large longitudinal study during which extensive relevant clinical data will be collected. If these digital endpoints were validated, we will seek support from EMA/FDA for their qualification. Patient users’ perspective, ethical, data privacy, legal and other regulatory issues will be taken into consideration in all aspects of our proposal. The resultant digital biobank from the longitudinal study will become an invaluable resource for future exploitation.
Funded Companies:
| Company name | Funding amount |
| Abbvie Inc. | €0.00 |
| Academisch Ziekenhuis Leiden | €134,500 |
| Asociacion Parkinson Madrid | €250,000 |
| Astrazeneca AB | €0.00 |
| Biogen Idec Ltd. | €0.00 |
| €0.00 | |
| Byteflies | €199,915 |
| €0.00 | |
| CHRISTIAN-ALBRECHTS-UNIVERSITAET ZU KIEL | €0.00 |
| Cambridge Cognition Ltd. | €150,000 |
| Dreem | €195,250 |
| EMPIRICA GESELLSCHAFT für KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG mbH | €473,750 |
| Ecrin European Clinical Research Infrastructure Network | €525,467 |
| Eli Lilly and Company Ltd. | €0.00 |
| Erasmus Universitair Medisch Centrum Rotterdam | €439,500 |
| European Federation OF Crohn'S AND Ulcerative Colitis Associations | €35,000 |
| F. HOFFMANN-LA ROCHE AG | €0.00 |
| FACULDADE DE CIENCIAS DA UNIVERSIDADE DE LISBOA | €0.00 |
| €350,000 | |
| €0.00 | |
| GEORGE-HUNTINGTON-INSTITUT GmbH | €328,075 |
| €0.00 | |
| Helse Stavanger HF | €244,500 |
| €289,500 | |
| Imperial College of Science Technology and Medicine | €2,345,530 |
| Institut Mines-Telecom | €356,750 |
| Instytut Psychiatrii i Neurologii | €170,000 |
| Ixscient Ltd. | €400,750 |
| Janssen Pharmaceutica N.V. | €0.00 |
| KKS-NETZWERK e. V. -NETZWERK DER KOORDINIERUNGSZENTREN für KLINISCHE STUDIEN | €0.00 |
| LET IT Care | €297,161 |
| €242,776 | |
| Manchester University NHS Foundation Trust | €0.00 |
| €159,125 | |
| Medibiosense Ltd. | €654,703 |
| €353,125 | |
| ORION Oyj | €0.00 |
| €0.00 | |
| Pfizer Ltd. | €0.00 |
| €287,500 | |
| Queen Mary University of London | €304,000 |
| Sanofi-Aventis Recherche & Developpement | €0.00 |
| Stichting Lygature | €401,485 |
| €200,000 | |
| TAKEDA PHARMACEUTICALS INTERNATIONAL AG | €0.00 |
| TEKNOLOGIAN TUTKIMUSKESKUS VTT Oy | €685,141 |
| TMF - TECHNOLOGIE UND METHODENPLATTFORM für DIE VERNETZTE MEDIZINISCHE FORSCHUNG e. V. | €360,000 |
| Takeda Development Centre Europe Ltd. | €0.00 |
| The Chancellor Masters and Scholars of the University of Cambridge | €595,165 |
| The University of Manchester | €167,500 |
| UCB Biopharma | €0.00 |
| UNIVERSITAET zu LUEBECK | €0.00 |
| UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN | €3,230,639 |
| UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK | €0.00 |
| €112,225 | |
| Universidad Autonoma de Madrid | €120,000 |
| Universita Degli Studi DI Brescia | €649,000 |
| University of Glasgow | €314,000 |
| University of Newcastle Upon Tyne | €4,644,337 |
Source: https://cordis.europa.eu/project/id/853981
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