Groups to Use Wearable Technology to Predict Parkinson’s Progression
In the late-phase clinical development program, patient data will be collected
Clinical Ink is partnering with a “leading biopharmaceutical organization” to monitor symptoms of people with Parkinson’s disease at home and clinical sites in the U.S. and Europe using the company’s technology.
This will be part of a late-phase clinical development program, in which symptoms of Parkinson’s patients will be collected through mobile and wearable technology for 18 months to identify markers that can help predict disease progression. The identity of the pharma organization was not disclosed.
“We are honored that our mobile and wearable technology plays an integral role in this study of Parkinson’s disease and to advance our development of digital [traits] and biomarkers,” Ed Seguine, CEO of Clinical Ink, said in a company press release.
Wearable technology paired with smartphone apps to collect data
Clinical Ink’s BrainBaseline platform relies on wearable technology paired with a smartphone application to collect data. Two types of data are collected: passive data, where measures are recorded as a patient goes about their day-to-day life, and active data, where a patient is instructed to perform a task or activity to measure something specific.
Based on more than a decade of data collection and research, the company has identified more than 3,000 measures that can be extracted from data collected via voice, movement, cognitive, and behavioral tasks.
“The team is now able to gather richer, more nuanced, and accurate data to enhance and support our models and advancement of digital biomarkers for clinical use,” said Joan Severson, chief innovation officer at Clinical ink.
“As the leaders in amassing Parkinson’s patient data (passive and active), we will be able to predict disease severity, progression, and therapeutic responsiveness,” Seguine added.
According to the company, the platform allows researchers to distinguish people in the early stages of Parkinson’s from those without the disease 92% of the time, with a sensitivity of 90% (true-positive rate) and a specificity of 100% (true-negative rate).
Combined with Clinical Ink’s smarter electronic clinical outcome assessment, or eCOA, the new program will look for associations between data measured via the company’s technology and standardized clinical assessments, such as the MDS-Unified Parkinson’s Disease Rating Scale and the Montreal Cognitive Assessment.
“The outcomes of this project will improve diagnosis, tracking and treatment of Parkinson’s while making clinical trials more efficient, leading to faster drug discovery not only for Parkinson’s, but potentially for a range of neurological conditions,” Severson said.
Earlier this year Clinical Ink announced results from a clinical trial called WATCH-PD (NCT03681015), which used the Apple Watch paired with an iPhone to collect both active and passive data on 132 people with and without Parkinson’s.
Analysis of the data with the BrainBaseline platform allowed the discrimination of early Parkinson’s patients from healthy volunteers with an 85% accuracy.