Digital biomarkers

Connected digital technologies, such as wearable biosensors and mobile devices, enable the passive measurement of parameters including sleep, activity and heart rate. This provides an opportunity to gather data continuously in a ‘real-world’ setting, revolutionizing data capture from CNS clinical trial participants.

With this data, we can extract more precise, patient-centric, clinically meaningful and objective new digital biomarkers compared to more traditional research methods, such as subjective rating scales and patient diaries.

Our approach to actigraphy

Actigraphy is a non-invasive method of monitoring human rest and activity cycles. It enables the collection of continuous rest-activity data, from which we can extract exploratory outcome measures on sleep, circadian rhythm and movement including physical activity or inactivity, gait, and other symptoms in movement disorders.

We utilize devices with 3-axis accelerometers, capable of recording at high frequency and storing raw data. For sleep assessment, patients typically wear a device on their wrist. For movement assessment, where sensors are best worn depends on the particular endpoint.  

Digital biomarker applications in sleep and movement

Actigraphy and digital biomarker analysis have a range of applications in CNS clinical trials, including:

  • Broad application across CNS diseases including Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease
  • Measuring sleep and general activity, as well as walking and balance
  • Collecting continuous real-world data from clinical trial subjects or patients
  • Complementing or replacing traditional tools (e.g. rating scales or diaries)

Find out more about applications of digital biomarkers

Applications in SLEEP

Sleep disruption is common in neurodegenerative diseases and CNS disorders and may contribute to brain pathology. Collecting sleep data during a clinical trial can provide important additional measures to aid the interpretation of results.

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Applications in MOVEMENT 

Movement analysis provides valuable information on functional performance in patients with CNS disorders. Wearable devices enable continuous measurement of clinically relevant parameters in real-world settings with a relatively low patient burden.

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Digital biomarker work at IXICO

 

We aim to improve the sensitivity and specificity of standard algorithms and their ability to measure physiological parameters such as sleep, activity and circadian rhythm. 

We are currently developing and validating new machine-learning, disease-specific algorithms to analyze wearable biosensor data. To support our innovation, we are funding studies to gather actigraphy data, alongside other clinical measures.

 

 

 

Digital biomarkers and the regulatory environment

Digital biomarkers provide pharma companies with supplemental, contextual information to arrive at clinical trial Go/No Go decisions more confidently and efficiently. 

Combining the best emerging wearable technology with our digital platform and scientific and regulatory expertise, we partner with biopharma companies across the globe to discover and clinically validate new digital biomarkers for deployment in regulatory compliant CNS clinical trials.

We are actively participating in consortia and engaging with regulatory bodies to develop the pathway to support the use of digital biomarkers as endpoints in clinical trials.

Want to find out more about how we can support your clinical study?

Download our latest brochure, or get in touch with us directly by emailing info@ixico.com.

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