Cambridge Cognition Holdings plc (LON:COG), which develops and markets digital solutions to assess all aspects of cognition, today announced it is part of a successful consortium of 46 industry and academic partners who have collectively been awarded a prestigious Innovative Medicines Initiative (“IMI”) grant. Led by the University of Newcastle, the consortium will work to identify digital endpoints for fatigue, sleep and activities of daily living in neurodegenerative disorders and immune-mediated inflammatory diseases. Cambridge Cognition will be the computerised cognitive assessment partner in the consortium and the proportion of the grant received by the Company is anticipated to be €150,000.
The IMI grant will fund a new European research project to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (acronym: “IDEA-FAST”) in the following neurodegenerative disorders: Parkinson’s disease and Huntington’s disease, and in the following immune-mediated inflammatory diseases: rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren’s syndrome, and inflammatory bowel disease; has been launched.
IDEA-FAST is a ground-breaking, €42 million digital health project co-funded by the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) under the Innovative Medicines Initiative Joint Undertaking programme. It consists of 46 members from 14 different European countries, including Cambridge Cognition, pharmaceutical companies, academic and not-for-profit institutions, small- and medium-sized enterprises and patient organisations aiming to play complementary roles in achieving the agreed goals.
Fatigue and sleep disturbances are common and disabling symptoms that affect patients with neurodegenerative disorders and immune-mediated inflammatory diseases impacting on daily activities; they are the major causes 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.
Based on the advancement of wearable and portable digital technology, IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue, sleep disturbances and disabilities in daily activities. The final goal is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of these symptoms in real-world settings. Such digital endpoints will eventually improve the efficiency of clinical trials, ultimately reducing the time and cost to bringing new therapies to patients.
The project, over its planned 66 month duration, will consist of two phases: an initial pilot study for testing and prioritising several digital devices and to identify candidate digital endpoints, followed by a large longitudinal study to validate findings for the most promising digital endpoints. The project will seek advice from regulatory agencies, including the European Medicines Agency, for the initial qualification of these digital endpoints. Patient users’ perspective, data privacy, ethical, legal and other regulatory issues will be taken into consideration at all stages of the project.
Matthew Stork, Chief Executive Officer of Cambridge Cognition, said:
“With advances in digital technology, and the widespread adoption of devices, data on patients’ functional outcomes can now be gathered at high-frequency in an objective and quantifiable manner. This offers huge potential for identifying and validating digital endpoints in clinical trials, and we are pleased to be the computerised cognitive assessment partner for this important collaborative initiative.”