Biogen recently announced a new digitally-powered virtual study in partnership with Apple to identify digital biomarkers to help monitor cognitive performance and health, including possibly identifying mild cognitive impairment, an early indicator of certain forms of dementia such as Alzheimer’s disease as well as assess overall cognitive health, that is the ability to think clearly, to learn, and to remember. Leveraging the Apple Watch and iPhone, the study will monitor and screen for cognitive performance indicators and overall cognitive health, including mild cognitive impairment (MCI). Publicly traded, Biogen (Nasdaq: BIIB) leads the multi-year observational research study starting later this year. The partners will enroll participants, including young and aging adults, exhibiting a range of cognitive performance. A powerful combination, what with Biogen’s in-depth knowledge of neuroscience and Apple’s market leading technology in the Apple Watch and iPhone. The primary objective of the study: develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI.
Cognitive health becomes an increasing topic of concern among aging adults. After all, this is a critical matter for whole person health—but significant delays exist in identifying declines in cognitive health including MCI, with impacts approximately 15-20% of adults over the age of 65. With symptoms subtle, ranging from slight memory loss to easy distraction, actually recognizing them by medical professionals can take months to years.
This virtual study, announced by Biogen, allows adult users across the aging lifespan to enroll and participate. Designed with customer private, control and transparency in mind—and data security—also embraces flexibility. For example participants can drop out at any time. Before participating, a subject must sign a consent form listing the collected data types and how each may be used and shared. Data in this study is stored in an encrypted database and travels in systems with what the sponsor terms strong security provisions.
Patient Advocacy Group POV
In the Biogen press release, George Vradenburg, Chairman and Cofounder of UsAgainstAlzhiemer’s, a patient-led non-profit pushing to prevent dementia through ongoing attention and awareness, commented, “Just as we today use new digital and mobile tools to help us monitor and improve our cardiovascular health, this new study will help us learn how to use those same tools to monitor and improve our brain health. We have learned repeatedly that detecting disease at its earliest stage is our best bet to treat it effectively. To that end, this exciting study could enable us to learn how to get early warning signs of cognitive decline which may be addressed through lifestyle and therapeutic changes designed to slow or stop the progression of brain disease.”
While Milken Institute executive director Nora Super commented, “strategies that optimize brain health and improve cognitive function are key to reducing the risk of dementia and this study has the potential to discover transformative ways to monitor and assess brain health.” Ms. Super continued, “We are always eager to see technological innovation, and we are particularly interested in the user convenience of data collected through the use of everyday devices like Apple Watch and iPhone. This type of innovation may enhance our understanding of the aging brain and therefore may ultimately help us understand how to maintain and improve brain health throughout adulthood.”
Biogen has Alzheimer’s Drug in Pipeline
Of course, this study will connect with Biogen’s investment in CNS-based investigational drugs targeting Alzheimer’s disease. Presently, there are no approved drugs for Alzheimer’s but there are existing therapies approved by the U.S. Food and Drug Administration (FDA) to treat the diseases symptoms including three cholinesterase inhibitors,” a memantine and a combination of cholinesterase inhibitors with memantine, reports the Alzheimer’s Association.
In August, Biogen and their partner Eisai Co. Ltd. announced that the FDA accepted their Biologics License Applications (BLA) for aducanumab, the investigational treatment for Alzheimer’s disease. Granted for Priority Review, the FDA has publicly declared its intention on acting on this application. The FDA’s final decision is expected by March 2021.