Is there a way out of ongoing failures?
Attempting to develop casual treatment against the progression of Alzheimer’s disease has resulted in unparalleled series of failures for nearly 2 decades of drug development. With the assessment of vast amounts of molecules and multiple billions of dollars burnt, Alzheimer’s disease is still the largest medial need to be addressed.
These series of failures has provided greater insights into the disease pathology, study methodologies and consequently – into the design of future development program for anti-Alzheimer medications.
Much of these paradigm shifts for study design are also applicable to other neurodegenerative diseases, such as ALS, Huntington’s, Parkinson’s and other movement disorders. And this has led our focus of design to be that of patient centricity.
Within the past decade, the complexity of most CNS studies increased. New technical modalities have been added; such as PET, SPECT, MRI, CSF and PK sampling as well as genotyping. There are only a few highly specialised centers that can offer all these tests. As a consequence, these top centers are overloaded with 10 or more studies at a time. The patients and their caregivers have to travel long distances to the centers and spend several days onsite to get all tests completed.
Clinically, highly relevant outcomes such as “Death” or “Requiring home care” would be an alternative solution for complex technical assessments; it would also lower the development costs because these endpoints are more easy and cheap to measure. These will however require longer observational periods of five to ten years. But, digital technology offers alternative solutions. Smartphones are widely available and have an array of inbuilt technology including accelerometers, gyroscopes, magnetometers, global positioning system (GPS), proximity sensors, ambient light sensors, microphones, cameras, touch-screen sensors. These sensors facilitate the measures of multiple data including activity, gait cadence, falls, speech, and location. Such assessments have the potential to make results more reliable and can offer a means of continuous longitudinal monitoring.
This article is an edited version of Can Digital Technology Advance the Development of Treatments for Alzheimer’s disease? J Prev Alz Dis, Published online Sept 2019. To view the full article, please visit http://www.jpreventionalzheimer.com/all-issues.html?article=495.