At the 15th International Virtual Conference on Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) 2021, during the pre-conference symposium, Roche presented the global challenges in the disease management of AD and emphasized learning from the experience of the ongoing COVID-19 pandemic to provide a global response to major health crises, which is an important part of tackling these global issues. Research on new and low-cost biomarkers is necessary to overcome diagnostic challenges and to allow early disease detection.

There is a great unmet need for simple, inexpensive, and non-invasive tests that could be applied on a large scale to screen for AD. Finding a biomarker in AD that translates into clinical meaningfulness has been a real challenge for biomarkers in the central nervous system (CNS). A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathological processes, or pharmacologic responses to a therapeutic intervention. The current method to definitively diagnose AD is through brain scans and tests of cerebrospinal fluid (CSF), which must be collected via lumbar puncture, but these procedures are invasive and expensive.

These challenges have created opportunities for biomarkers that can be measured in a simple way and that are also less invasive and less expensive, such as blood biomarkers or digital biomarkers, as biomarkers could facilitate early diagnosis of AD, especially in countries with a high prevalence of the disease. Moreover, biomarkers could facilitate patient assessment prior to enrolment in clinical trials, as it could help exclude patients with underlying conditions that could mimic or aggravate the symptoms of AD.

According to GlobalData’s Pharma Intelligence Center, AD is the major indication in the CNS being targeted for the development of drugs involving biomarkers, with a total of 902 clinical trials being conducted globally. Globally, the Aβ, tau, and APOE proteins are being targeted the most as biomarkers in AD. There are currently three FDA- and European Medicines Agency (EMA)-approved diagnostic tests for AD, all of which are positron emission tomography (PET) neuroimaging scans capable of detecting beta-amyloid plaques in the brains of living patients. The first diagnostic test for AD was approved in 2012.

Changes in biomarkers can occur many years before AD symptoms start, and the scientific literature has shown that biomarkers can help to differentiate AD from other types of dementia in the early stages. If physicians can easily and effectively detect AD in its early stages, they can enrol patients in experimental trials for preventative treatments. This would be doubly beneficial, as a lack of qualified patients being available for clinical trials is one of the primary reasons for drug trial failures in AD. Evaluating patients more carefully and referring them to specialists who can administer more complex cognitive exams or utilize the latest diagnostic biomarker tools can confirm an AD diagnosis. Using this confirmation, researchers can develop preventative treatments that are most likely to be effective against AD and to offer patients a more personalized approach to treatment.