Topic / Target
>IMI2-2015-03-01 Remote Assessment of Disease and Relapse (RADAR) programme - Central Nervous System (CNS)
The RADAR-CNS proposal seeks to address/utilise two important aspects of CNS diseases. Firstly, most CNS diseases are dynamic in nature with multiple reoccurrences and relapses each of which accelerate the downward spiral of the underlying disease pathology and lead towards chronification, morbidity and mortality.
Secondly, the onset of reoccurrences, exacerbations and relapses in CNS disease causes changes in parameters related to sleep, physical activity, speech, cognition, social connectivity, memory etc.; parameters that can increasingly be measured remotely and passively via unobtrusive on-body biosensors and
The vision of RADAR-CNS is to reduce cost and trauma to the patient and care-givers and reducing hospitalisations by predicting and pre-empting relapses and reoccurrences via the use of remote assessment technologies. RADAR-CNS will focus initially on unipolar depression, multiple sclerosis (MS) and epilepsy with the main goal of using available clinical information and streaming data from on-body sensors to predict relapse, symptom exacerbations and seizures respectively. Initial RADAR disease were selected on the basis of unmet need in terms of prevalence, disability caused, feasibility of developing a remote biosignature predictive of a change in disease state, and the therapeutic interests of contributing EFPIA companies. Depression, MS and epilepsy are prevalent, disabling conditions that effect all age-groups, and are characterised by rapid and distinct changes in disease states at varying time-scales that, if predicted and pre-empted, would result in significant improvement in overall patient outcomes. Furthermore, depression and MS are often co-morbid in a patient, thus offering opportunities to study both diseases in a common population. It should be noted that learnings in terms of sensor development, data management, analytics, privacy, regulatory and health-care policy issues etc. will transfer to other disease areas in this topic. Indeed, the long-term goal is to build upon the learning of the first three diseases and in the future include other disease areas such as bipolar disease, Alzheimer’s disease, schizophrenia and pain.
The aim of RADAR-CNS is the characterisation and prediction of changes in disease state in central nervous system (CNS) disorders via non-invasive remote sensing.
This topic is planned to be focused on the three diseases of unipolar depression, multiple sclerosis and epilepsy. For each disease it is proposed that a non-interventional/observational study of subjects is undertaken with three objectives:
* Characterisation of changes in disease state.
* Characterisation of changes in disease state due to drug effects.
* Prediction of change in disease state from remote sensing data.
To co-ordinate across all three disease areas a common set of measures and measurements tools will be used to track the sleep architecture, physical activity, speech, cognition, social connectivity, and memory of subjects of all of the target diseases.
Expected key deliverables
1) Candidate bio-signatures that predict relapse and track disease state changes in MS, depression and epilepsy using at least a common minimal set of metrics: sleep architecture, physical activity, speech, cognition, social connectivity, and memory.
2) Development of algorithms and an analytic infrastructure suitable for collecting and analysing data from the RADAR-CNS studies.
3) Proposal of actionable privacy and usability parameters that would drive eventual uptake of, and adherence to, remote assessment solutions in CNS diseases.
4) Delineation of putative regulatory pathways necessary for approval of remote sensing solutions in real-world patients. This deliverable will be developed in consultation with regulators.
5) Delineation of putative clinical care pathways and use cases of remote-sensing solutions and how they impact and interface with stake-holders such as patients, care-givers, case-managers, physicians etc.