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IDEA-FAST SIGNED

Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities in daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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Project "IDEA-FAST" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITY OF NEWCASTLE UPON TYNE 

Organization address
address: KINGS GATE
city: NEWCASTLE UPON TYNE
postcode: NE1 7RU
website: http://www.ncl.ac.uk/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Total cost 40˙922˙058 €
 EC max contribution 20˙997˙522 € (51%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2018-15-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2019
 Duration (year-month-day) from 2019-11-01   to  2025-04-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) coordinator 6˙226˙301.00
2    IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE UK (LONDON) participant 2˙345˙530.00
3    UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN DE (Lübeck) participant 2˙247˙065.00
4    THE CHANCELLOR MASTERS AND SCHOLARSOF THE UNIVERSITY OF CAMBRIDGE UK (CAMBRIDGE) participant 720˙165.00
5    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 707˙182.00
6    Teknologian tutkimuskeskus VTT Oy FI (Espoo) participant 575˙141.00
7    STICHTING MLC FOUNDATION NL (DEN HAAG) participant 500˙000.00
8    LIXOFT SAS FR (ANTONY) participant 499˙937.00
9    EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH DE (BONN) participant 473˙750.00
10    TMF - TECHNOLOGIE UND METHODENPLATTFORM FUR DIE VERNETZTE MEDIZINISCHE FORSCHUNG EV DE (BERLIN) participant 460˙000.00
11    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL (ROTTERDAM) participant 439˙500.00
12    IXSCIENT LIMITED UK (TWICKENHAM MIDDLESEX) participant 400˙750.00
13    GEORGE-HUNTINGTON-INSTITUT GMBH DE (MUNSTER) participant 358˙950.00
14    MEDIZINISCHE UNIVERSITAT INNSBRUCK AT (INNSBRUCK) participant 353˙125.00
15    UNIVERSITY OF LIMERICK IE (LIMERICK) participant 352˙225.00
16    THE UNIVERSITY OF MANCHESTER UK (MANCHESTER) participant 347˙000.00
17    UNIVERSITA DEGLI STUDI DI BRESCIA IT (BRESCIA) participant 344˙500.00
18    INSTITUT MINES-TELECOM FR (PALAISEAU) participant 326˙750.00
19    UNIVERSITY OF GLASGOW UK (GLASGOW) participant 314˙000.00
20    QUEEN MARY UNIVERSITY OF LONDON UK (LONDON) participant 304˙000.00
21    INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES PT (LISBOA) participant 289˙500.00
22    PLURIBUS ONE SRL IT (CAGLIARI) participant 287˙500.00
23    FCIENCIAS.ID - ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS PT (LISBON) participant 280˙000.00
24    ASOCIACION PARKINSON MADRID ES (MADRID) participant 250˙000.00
25    HELSE STAVANGER HF NO (STAVANGER) participant 244˙500.00
26    UNIVERSIDAD AUTONOMA DE MADRID ES (MADRID) participant 230˙000.00
27    BYTEFLIES BE (ANTWERPEN) participant 199˙915.00
28    DREEM FR (PARIS) participant 195˙250.00
29    INSTYTUT PSYCHIATRII I NEUROLOGII PL (WARSZAWA) participant 170˙000.00
30    CAMBRIDGE COGNITION LIMITED UK (CAMBRIDGE) participant 150˙000.00
31    MCROBERTS BV NL (S GRAVENHAGE) participant 147˙750.00
32    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 134˙500.00
33    MEDIBIOSENSE LTD UK (DONCASTER) participant 87˙735.00
34    EUROPEAN FEDERATION OF CROHN'S AND ULCERATIVE COLITIS ASSOCIATIONS BE (BRUXELLES) participant 35˙000.00
35    ABBVIE INC US (NORTH CHICAGO IL) participant 0.00
36    ASTRAZENECA AB SE (SODERTAELJE) participant 0.00
37    BIOGEN IDEC LIMITED UK (MAIDENHEAD) participant 0.00
38    Eli Lilly and Company Limited UK (Basingstoke) participant 0.00
39    F. HOFFMANN-LA ROCHE AG CH (BASEL) participant 0.00
40    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 0.00
41    ORION OYJ FI (ESPOO) participant 0.00
42    PARKINSON'S DISEASE SOCIETY OF THEUNITED KINGDOM LBG UK (LONDON) participant 0.00
43    PFIZER LIMITED UK (SANDWICH) participant 0.00
44    SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT FR (Chilly Mazarin) participant 0.00
45    TAKEDA DEVELOPMENT CENTRE EUROPE LTD UK (LONDON) participant 0.00
46    UCB BIOPHARMA SRL BE (BRUXELLES) participant 0.00

Map

 Project objective

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.

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The information about "IDEA-FAST" are provided by the European Opendata Portal: CORDIS opendata.

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