Biogen has announced a new multiyear research study on cognitive decline that will be conducted using the Apple Watch and iPhone.
The observational study is being conducted in collaboration with Apple, according to the announcement, and is set to kick off later this year. The project's primary goal is to establish digital biomarkers for monitoring long-term cognitive performance and to spot early signs of mild cognitive impairment (MCI).
Biogen said it will be enrolling "young and aging adults" into its virtual study. The company said it has designed the project's consent form to keep patients in the loop on how their data is being collected and used, and all collected data will be encrypted to ensure privacy. Enrollees can end their participation at any time.
“Working in collaboration with Biogen, we hope this study can help the medical community better understand a person's cognitive performance by simply having them engage with their Apple Watch and iPhone,” Jeff Williams, Apple’s COO, said in a statement.
WHY IT MATTERS
About 15-20% of adults aged 65 years or older experience MCI, and according to the NIH roughly 80% of those who meet the definition of amnestic MCI (where memory is significantly impaired) will develop Alzheimer's disease.
Definitive diagnosis for both MCI and Alzheimer's can be costly and time-consuming for patients, John Dwyer, president of the Global Alzheimer's Platform Foundation, said in a separate statement reacting to the study announcement. Digital biomarkers developed through this type of project could thereby increase access to care for a broad range of individuals.
"We applaud the decision to open this study to adults of all ages and cognitive abilities, giving researchers the ability to track brain health over time and better understand the earliest indicators of decline," Dwyer said in the statement. "As we wish them well with this important study, we urge Biogen and Apple to prioritize recruiting and providing access to a diverse universe of study participants that includes Black and Hispanic participation at rates that match the incidence of MCI and Alzheimer’s in those communities."
Biogen echoed these points in its announcement and also highlighted the benefits these digital biomarkers could offer health systems.
“The successful development of digital biomarkers in brain health would help address the significant need to accelerate patient diagnoses and empower physicians and individuals to take timely action,” Michel Vounatsos, CEO at Biogen, said in a statement. “For healthcare systems, such advancements in cognitive biomarkers from large-scale studies could contribute significantly to prevention and better population-based health outcomes, and lower costs to health systems. Bringing together the best of neuroscience with the best of technology creates a wonderful prospect for patients and public health.”
THE LARGER TREND
This study with Biogen is another notch for Apple's swelling health research efforts.
In the past year alone, the tech company kicked off the Heartline Study with Johnson & Johnson and Evidation Health to engage the Medicare population in a device-driven cardiovascular health program. It later backed a University of California, Los Angeles study focused on depression and anxiety, and paired its September device reveals with the announcement of three new digital health research studies on asthma, heart failure and respiratory infections.
That's not to say that Apple is the only tech giant homing in on mobile- and device-supported clinical research. Alphabet has offered investigators a tailored smart wearable called the Verily Study Watch since 2017, but ramped up its efforts in December with the introduction of the Google Health Studies app. Developed by the Google Health team, this tool allows users to view a list of open virtual studies being conducted by partnered research organizations, review their inclusion criteria and participate all from their Android smartphone.