The future of Alzheimer’s disease (AD) diagnosis and management has been a key theme at the AD/PD 2023 International Conference on AD and Parkinson’s disease (PD). This has become a particularly pressing hot topic now that disease-modifying therapies (DMTs) able to halt disease progression are becoming a reality, following the FDA approvals of Biogen’s Aduhelm (aducanumab) in 2021 and Eisai and Biogen’s Leqembi (lecanemab) in January 2023, meaning that earlier, more timely diagnosis can have a significant impact on disease progression and quality of life for patients. This is an important topic for developers who will be looking for the best way to integrate their therapies into AD treatment algorithms and best practices to ensure maximum uptake. Lilly, Roche, and Novo Nordisk all sponsored symposiums at AD/PD 2023 discussing the current AD patient clinical care pathway, the challenges involved in timely diagnosis and management of AD, and the growing opportunities in the management of AD.
Currently, significant barriers and challenges exist in diagnosing and managing AD. These include a lack of awareness of brain health and cognitive impairment in the general population and among primary care physicians, meaning detection of cognitive impairment is low in primary care settings. There also tend to be delays in referral to specialists, with substantial wait times for an AD diagnosis experienced globally; this will delay the initiation of DMTs, which is likely to reduce the positive impact these therapies can have. A key part of improving the diagnosis and management of AD will be the role that biomarkers, particularly blood-based biomarkers (BBBMs), will play in the future. As such, there were multiple forums, symposiums, and industry-sponsored sessions across AD/PD 2023 that focused on BBBMs for AD, the progress being made in this field, the current uses and abilities of these biomarkers, and their potential role in future AD diagnosis and management.
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BBBMs have the potential to be incorporated into existing diagnostic frameworks to help streamline the process. Once highly validated BBBM tests become widely available, an initial blood test in a primary care setting for patients with cognitive symptoms could highlight patients who are at high risk of progressing to AD, who could be fast-tracked to receive DMT; patients with a medium probability of progressing to AD, who could be referred to specialists to confirm a diagnosis using clinical assessment and current gold-standard imaging and cerebrospinal fluid (CSF) biomarkers for AD; and patients at low risk of progressing to AD, who could then be evaluated for an alternative diagnosis. Plasma phosphorylated tau (p-tau) is currently considered to be the best BBBM to diagnose AD, although there is some debate about which p-tau epitope is best, p-tau181 or p-tau217, and many companies, such as Lilly, are looking to develop a p-tau–based BBBM in conjunction with their DMTs. Numerous other BBBMs are also being investigated including plasma amyloid-beta42/40, plasma neurofilament light, and plasma glial fibrillary acidic protein, with some experts advocating for a combined approach where a panel of different BBBMs are used together for AD diagnosis.
While experts are excited by the prospects of BBBMs and the potential they have to increase and speed up diagnosis, they were quick to highlight the important role that clinical evaluation of symptoms still has and the dangers of moving to diagnosis based on a single biomarker result. Further, experts highlighted that BBBMs cannot be developed and introduced into primary care in isolation and are expected to make a significant impact. An important aspect of improving diagnosis through the use of BBBMs will be increased physician education, and clear guidelines and best practices on how to use and interpret results from BBBM tests, especially if these tests involve evaluating a panel of different biomarkers as opposed to one specific biomarker.
Ultimately the goal for AD is for prevention of disease rather than just slowing progression and managing symptoms. As this will only be achieved by therapeutic intervention prior to the development of symptoms, biomarkers will also play a crucial role in prevention strategies. The development of non-invasive, relatively cheap, and easy-to-use biomarkers for this could enable widespread use in routine screening, with some experts advocating for these to be used for all patients during routine clinical checkups, so that brain health is monitored in the same way as blood pressure, for example. Research into identifying and evaluating what these biomarkers could be is ongoing and is likely to become a growing area of interest in AD.
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