IDEA-FAST

Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurodegenerative disorders and immune-mediated inflammatory diseases
IDEA-FAST logo

FACTS & FIGURES

Start Date
End Date
Call
IMI2 - Call 15
Grant agreement number
853981

Type of Action: 
RIA (Research and Innovation Action)

Contributions
IMI Funding
20 997 523
EFPIA in kind
19 262 286
Associated Partners
197 250
Other
465 000
Total Cost
40 922 059

Summary

Fatigue and sleep disturbances are common symptoms of many chronic diseases, and are associated with a poor quality of life and greater healthcare costs. Today, efforts to measure these symptoms, e.g. in clinical trials, are based largely on standardised paper questionnaires, which do not give very reliable results.

The aim of IDEA-FAST is to identify digital endpoints for fatigue and sleep disturbances that will provide a more sensitive, reliable measure of the severity and impact of these symptoms in a real life setting. They will do this by identifying the characteristics of fatigue and sleep disturbances and the digital endpoints that could quantify them. They will then select the digital devices and technologies that could measure and record these symptoms. They will also design a secure digital management platform to support the acquisition, storage and analysis of the data.

All of this will be validated in a pilot study involving patients with neurodegenerative diseases (Parkinson’s disease and Huntington’s disease) and immune-mediated inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren’s syndrome, and inflammatory bowel disease).

In addition to gaining new insights into the mechanisms behind fatigue and sleep disturbances, IDEA-FAST’s results should dramatically improve the efficiency of clinical trials, and so speed up the development of new treatments for these chronic diseases.

Achievements & News

Mobilise-D and IDEA-FAST team up on digital health technologies
February 2021

Mobilise-D and IDEA-FAST, two IMI projects that aim to develop real-world digital outcomes, have announced their plan to collaborate, to bring synergy and increase the impact and benefits of the digital health technologies developed by both projects. ###The collaboration will exploit common themes and approaches across the projects, to develop digital biomarkers in mobility, sleep and fatigue, including large observational studies involving diverse patient cohorts. The topics of collaboration include areas such as ethics, principles of external data-sharing, regulatory approaches, dissemination activities, training and education, and working with stakeholders.

Professors Lynn Rochester and Wan-Fai Ng from Newcastle University, the coordinators of Mobilise-D and IDEA-FAST respectively, state: ‘We are delighted with this collaboration which cements the intended relationship seen from the inception of the projects, and look forward to the extended impact and reach possible by formalising our ongoing collaboration.’

For their part, the projects’ EFPIA leads, Dr Ronenn Roubenoff (Novartis, Mobilise-D) and Dr Frederic Baribaud (Janssen, IDEA-FAST) identify the future benefits of the inclusion of digital biomarker approach in clinical trials to develop and evaluate pharmaceutical interventions.

Professor Walter Maetzler, who participates in both projects commented: ‘What could be more advantageous than to consistently combine the strengths of both projects and thus increase the impact for patients and medicine?’

Mobilise-D focuses on mobility assessment in chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis and proximal femoral fracture and IDEA-FAST on the assessment of fatigue, sleep disturbances and instrumental activities in neurodegenerative disorders (Parkinson’s disease, Huntington’s disease) and immune-mediated inflammatory diseases (inflammatory bowel diseases, lupus, rheumatoid arthritis, Sjogren’s syndrome). Both projects aim to develop and validate digital biomarkers towards regulatory approvals.

Find out more

Unravelling the enigma of autoimmune diseases – an opinion piece by Pierre Meulien
June 2020

We like to think of the immune system as a surveillance mechanism for the body that’s standing guard, ready to weed out and kill anything harmful. But for people with an autoimmune disorder, it doesn’t work that way; deregulated, it fights our own tissue instead of protecting it. ###And while we might have some success in treating the symptoms, we are largely in the dark as to why treatments work for some and not for others, as well as what triggers the disease in the first place. In an opinion piece published on the IMI website, IMI Executive Director Pierre Meulien explores IMI’s portfolio in this important disease area.

‘One of things that IMI is particularly proud of is the progress we’ve made in the reclassification of subtypes of disease, which means redefining diseases based on their biology and not just symptoms,’ he writes. ‘It’s an extremely scientifically complex area, and we’re steadily increasing the level of understanding of the molecular drivers in a number of disease areas.’

IMI is also very active in remote assessment. ‘This tech convergence is a trend, and we will see more and more sophisticated remote monitoring which will change the game in clinical trials,’ writes Dr Meulien, citing IMI’s Trials@Home and IDEA-FAST projects.

Find out more

Participants Show participants on map

EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Astrazeneca AB, Södertälje, Sweden
  • Biogen Idec Limited, Maidenhead, Berkshire, United Kingdom
  • Eli Lilly and Company Limited, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Orion Oyj, Espoo, Finland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
  • UCB Biopharma SRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Leiden, Leiden, Netherlands
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • Fciencias.Id - Associacao Para A Investigacao E Desenvolvimento De Ciencias, Lisbon, Portugal
  • Helse Stavanger Hf, Stavanger, Norway
  • Imperial College Of Science Technology And Medicine, London, United Kingdom
  • Institut Mines-Telecom, Paris, France
  • Instituto De Medicina Molecular Joao Lobo Antunes, Lisboa, Portugal
  • Instytut Psychiatrii I Neurologii, Warszawa, Poland
  • Medizinische Universitat Innsbruck, Innsbruck, Austria
  • Queen Mary University Of London, London, United Kingdom
  • Teknologian Tutkimuskeskus Vtt Oy, Espoo, Finland
  • The University Of Manchester, Manchester, United Kingdom
  • Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev, Berlin, Germany
  • Universidad Autonoma De Madrid, Madrid, Spain
  • Universita Degli Studi Di Brescia, Brescia, Italy
  • Universitatsklinikum Schleswig-Holstein, Lübeck, Germany
  • University Of Glasgow, Glasgow, United Kingdom
  • University Of Limerick, Limerick, Ireland
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
  • University of Cambridge, Cambridge, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Byteflies, Antwerpen, Belgium
  • Cambridge Cognition Limited, Cambridge, United Kingdom
  • Dreem, Paris, France
  • Empirica Gesellschaft Fur Kommunikations Und Technologieforschung Mbh, Bonn, Germany
  • George-Huntington-Institut GMBH, Munster, Germany
  • Ixscient Limited, Uxbridge, United Kingdom
  • Lixoft SAS, Orsay, France
  • Mcroberts BV, S Gravenhage, Netherlands
  • Medibiosense LTD, Doncaster, United Kingdom
  • Pluribus One SRL, Cagliari, Italy
  • Stichting Mlc Foundation, Den Haag, Netherlands
Patient organisations
  • Asociacion Parkinson Madrid, Madrid, Spain
  • European Federation Of Crohn'S And Ulcerative Colitis Associations, Bruxelles, Belgium
Associated partners
  • Parkinson'S Disease Society Of Theunited Kingdom Lbg, London, United Kingdom
Third parties
  • Christian-Albrechts-Universitaet Zu Kiel, Kiel, Germany
  • Faculdade De Ciencias Da Universidade De Lisboa, Lisboa, Portugal
  • Fundacion Para La Investigacion Biomedica Del Hospital Universitario Clinico San Carlos, Madrid, Spain
  • Greater Glasgow Health Board, Glasgow, United Kingdom
  • Kks-Netzwerk Ev -Netzwerk Der Koordinierungszentren Fur Klinische Studien, Berlin, Germany
  • Manchester University Nhs Foundation Trust, Manchester, United Kingdom
Non EFPIA companies
  • CHDI Foundation, Inc., New York, United States
Project coordinator
Wan-Fai Ng
University Of Newcastle Upon Tyne