The COVID-19 pandemic has put considerable strain on the healthcare services across the globe and is impacting clinical development across many therapeutic areas, as many resources are being diverted to fighting the pandemic.

Disruptions to clinical trials in areas such as oncology and neuroscience are down to many reasons, including strict government lockdown measures preventing patients from visiting clinics and a shift in hospital resources away from non-essential procedures to prioritise the treatment of COVID-19 positive patients. In addition, a core principle of any clinical trial design is to mitigate the risk of harm to the study participant. COVID-19 represents an additional risk that must now be considered. For Alzheimer’s disease, this may be a particular issue since the symptomatic onset of this condition is more likely to occur after 65 years old and are more vulnerable to developing serious complications from COVID-19.

Therefore, biopharma companies conducting clinical trials that recruit patients for diseases focused on an older age demographic are having to postpone, suspend or rethink their clinical studies and adopt alternative strategies to continue with their clinical development.  This in turn is driving innovation in digital healthcare, since these strategies to protect vulnerable clinical trial participants are largely focused on developing and deploying remote monitoring solutions that can reliably monitor a patient’s symptoms and their progression and bypass the need to visit study clinics in person.

Even before the emergence of COVID-19, wearables have shown to be important when developing early clinical endpoints for neurodegenerative disease, with University College London (UCL) recently announcing a global initiative, ‘Early Detection of Neurodegenerative diseases (EDoN)’ led by Alzheimer’s Research UK, to utilise wearable technology to gain digital health data on sleep, movement and speech patterns and help develop early digital fingerprints for neurodegenerative diseases such as Alzheimer’s disease. Recent research has also demonstrated the value of wearables data in assessing the motor activity and sleep quality in other areas of the central nervous system.  These wearable devices continuously measure movement (ie “actigraphy”) typically using an accelerometer, which may be worn on the wrist or attached to clothing.

As an example, IXICO’s recent work with a biopharma company explored the sleep-wake cycle in patients with schizophrenia receiving long-acting injectable (LAI) antipsychotic treatment in a randomized, double-blind clinical trial in recently stabilized outpatients. The data acquired from this study was analysed using IXICO’s validated algorithms to interpret data from wearable biosensors. Although an exploratory endpoint, this demonstrated the feasibility of measuring sleep and movement in stabilised patients with schizophrenia in an outpatient setting. The actigraphy results generated in this trial were consistent with previously published sleep and activity patterns, which have demonstrated longer total sleep times and lower average activity levels in patients with schizophrenia compared with the general population.

IXICO’s R&D programme continues to develop new actigraphy solutions for clinical trials across a range of neurological indications. Recently, we presented a research poster at the Advances in Alzheimer’s and Parkinson’s Therapies (AAT-ADPD) conference that demonstrated the superior performance of our AI algorithm for sleep detection in Parkinson’s disease patients compared with traditional feature designed algorithms.

IXICO’s approach centres on development of “device-agnostic” algorithms for actigraphy, meaning that the same algorithm can be deployed on different studies, regardless of which wearable biosensor is selected. The device-agnostic solution was developed using data from the CONTEXT study (in collaboration with Centre Hospitalier Universitaire, Montpellier, France) as well as public actigraphy databases. Scientific results from this collaboration are currently under review for publication.

As we adapt our daily lives and working practices in response to the COVID-19 pandemic, the phrase “necessity is the mother of invention” has never run truer.  The need to protect patients and the wider population is driving digital health innovation at pace and has already opened up greater opportunity for virtual clinical trials that rely on remote monitoring rather than in person clinic visits. 

There is no doubt there will be a lasting impact of COVID-19 on our health services and on society as a whole, and key learnings will be used to improve our response to future pandemics at every level and the implementation of fundamental technology will be vital in keeping us all safe and well.

---