Biogen, Apple to Initiate Study to Develop Cognitive Health Digital Biomarkers

Maha Radhakrishnan, MD

This month, Biogen announced that it has partnered with Apple for a new, virtual, multi-year, observational study assessing the potential of the Apple Watch and iPhone in monitoring the cognitive performance of individuals and screening them for declines in cognitive health, including conditions such as mild cognitive impairment (MCI).

Biogen noted that it expects to launch the study later in 2021, anticipating an enrollment of both young and aging adults across the breadth of cognitive performance levels. Jeff Williams, chief operating officer, Apple, said in a statement that the company is looking forward to exploring how it might leverage its technology “in delivering better health outcomes through improved detection of declining cognitive health.”

The study aims to develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI, and Biogen stated that it was designed with customer privacy, control, and transparency, as well as data security in mind. The participants are able to halt their participation at any time and will be required to complete a detailed consent form that includes the collected data types and how they may be used and shared. Data will be encrypted manner and stored in systems with “strong security controls designed to protect the data,” the company stated.

To find out more about the study and what the clinical community should look forward to as this venture gets underway, NeurologyLive inquired with Maha Radhakrishnan, MD, Group SVP, Chief Medical Officer, Biogen.

NeurologyLive: How does this partnership speak to the incorporation of technology—particularly in light of the uptick in telemedicine use—in the study of neurologic and neurodegenerative diseases?

Maha Radhakrishnan, MD: As we have seen over the last several years, technology is revolutionizing the way we think about healthcare by putting patients at the center and empowering them to track and manage their health. Studying the use of novel technology in healthcare aligns with Biogen’s role as a pioneer in neuroscience, and we are proud to collaborate with Apple on this study.

What is the goal of the project and is there a target enrollment for the study?

This study will look at how Apple Watch and iPhone could potentially play a role in monitoring cognitive performance and screening for changes in cognitive health including mild cognitive impairment. We also anticipate the study may help answer other questions related to cognition and aging. These additional research topics will be disclosed to study participants as part of the informed consent process. We will provide more details about the study prior to study launch.

Overall, what should the physician community know about this collaboration and how might the data better inform clinical practice and diagnosis?

Biogen believes digital technology will become increasingly important in clinical practice. This collaboration aims to study how Apple Watch and iPhone may be used to monitor cognitive performance and brain health. It is our belief that digital biomarkers of cognitive health based on consumer devices could empower patients to better manage their health. In the healthcare setting, they may also be useful for identifying the appropriate patients for cognitive screening and helping to identify cognitive decline at an early stage. More efficient and earlier diagnosis of cognitive impairment could lead to better population-based health outcomes, and lower costs to health systems in the future.

Transcript edited for clarity.

REFERENCE
Biogen to launch pioneering study to develop digital biomarkers of cognitive health using Apple Watch and iPhone. News release. January 11, 2021. Accessed January 12, 2021. https://investors.biogen.com/news-releases/news-release-details/biogen-launch-pioneering-study-develop-digital-biomarkers