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As we mark the close of World Alzheimer’s Month, we have a vital and urgent opportunity to demand change. Europe is poised to enter a new era in Alzheimer’s disease (AD) care, which could reduce the toll that this devastating condition places on families, healthcare systems and budgets across the region. Achieving this success, however, will only be possible by enhancing timely and accurate diagnosis of AD and ensuring all EU patients have equitable access to breakthroughs in diagnostics and treatment. For World Alzheimer’s Month and beyond, it is imperative that Members of the European Parliament prioritize policy changes that champion innovation and help make this evolved approach a reality.
Timely, accurate diagnosis is vital to connect patients with new treatment innovations
The hallmarks of AD can begin appearing in the brain about 20 years before the onset of memory decline and other symptoms.[i] Encouragingly, individuals diagnosed in these early stages of AD could soon benefit from a new generation of disease modifying therapies that target the underlying causes of AD in its early stages, aiming to slow or alter disease progression and reduce functional decline.[ii] While patients in some parts of the world are already seeing the benefits of these therapies, widespread access is not currently available to those living in the EU. Timely and accurate clinical diagnosis is also crucial to identify the right patients at the right time who could benefit from these advancements.11,13
Less than half of those with AD will ever be diagnosed due to failures of current approaches
Despite increasing levels of awareness, fears and stigmas lead about 50% of people living with AD and their caregivers to delay seeking a diagnosis.[iii] As a result, few individuals with mild cognitive impairment or early dementia due to AD seek medical help.[iv] Additionally, most current diagnostic tools are less effective in the early stages of AD, when symptoms are subtle and functional impairment is not yet evident.[v] These challenges, combined with capacity issues, mean it can take over two years after symptoms first appear for a diagnosis to be made,[vi] by which time the disease has often progressed significantly.
As a result, less than 50% of individuals living with dementia will ever be given a diagnosis[vii] and most are diagnosed too late for effective treatment.
Blood based biomarkers hold the key to accelerating AD diagnosis for more patients
Biomarker testing is a key component of the timely, accurate diagnosis of AD. These tests can identify pathogenic processes of AD in the brain and quickly rule out false-negative diagnoses.[viii] Until recently biomarker testing in AD could only be conducted via PET scans or testing patient’s cerebrospinal fluid, however researchers have recently identified blood-based biomarkers that can diagnose AD via a simple blood test.
This breakthrough has the potential to not only make accurate, rapid diagnosis of AD more accessible and affordable, but could radically improve the patient experience by avoiding the need for scans and lumbar punctures. As well as highlighting the presence or severity of AD and helping to predict and monitor disease progression, blood biomarkers can also be used to more accurately identify patients who are most likely to benefit from novel treatment options in the earlier stages of disease.[ix]
Unfortunately, while some European countries have seen strong uptake of biomarker testing for AD – such as Sweden, the Netherlands, and Germany[x] – this is not reflected across the whole region. According to a recent study, only 2 – 10% of AD diagnoses are based upon biomarker testing.[xi]
“Up to 30% of patients are misdiagnosed if biomarkers are not used, they don’t have AD even if they have symptoms resembling those of AD. By using biomarkers, we can ascertain the underlying pathology to exclude or confirm AD”, says Stéphane Epelbaum, International Medical Leader Neuroscience, Eli Lilly & Company.
Policymakers have a role to play in championing innovations across the AD pathway
The importance of policy change in advancing new diagnostics for AD was raised at this year’s Alzheimer’s Disease International (ADI) Conference by Chris Lynch, Deputy CEO & Director of Policy, Communications & Publications at ADI. He urged decision makers to adopt a holistic approach that takes into consideration the entire diagnostic pathway of AD and its many challenges. Lynch also suggested that discussions regarding value should broaden their focus from the cost of new tools to better include the opportunities they can offer by enabling early diagnosis.
Encouragingly, a similar policy focus in cancer care has improved access to novel diagnostics, such as biomarker testing.[xii] Replicating this approach for AD could significantly expand the application of such tests and deliver early, accurate diagnosis on a much wider scale.[xiii]
“Innovative diagnostics have a key role to play in streamlining the AD patient pathway and helping families affected by AD gain back more precious time together. We are calling on policymakers to take bold action to help realize the impact of these breakthroughs,” says Lynch.
It is time to BE PIONEERING by embracing transformative innovations
Successfully implementing innovations in AD diagnostics and treatment can transform lives, easing the burden for patients, families and health systems. However, this transformation hinges on policymakers recognizing timely and accurate diagnosis of AD as a public health priority.
The arrival of new disease-modifying therapies for Alzheimer's disease should serve as a catalyst for change. In parallel, a recent survey by ADI has highlighted public demand for new treatment approaches in AD, with over 90% of respondents confirming they would be more likely to seek a diagnosis of AD if such treatments were available.[xiv] In response, policymakers must seize this opportunity to adapt health care policies and fully embrace these exciting breakthroughs.
By supporting access to diagnostic innovation, we can empower clinicians to make personalized treatment decisions together with their patients, just as they do for other serious diseases. Most importantly, by consistently advocating for timely and accurate diagnosis for all patients we can give those affected by this devastating disease more precious time with their loved ones.
References
[i] Bateman RJ, Xiong C, Benzinger TL, et al. Clinical and biomarker changes in dominantly inherited Alzheimer’s disease. N Engl J Med. 2012; 367: 795-804: https://www.nejm.org/doi/full/10.1056/NEJMoa1202753.
[ii] Pais M, Martinez L et al. Early diagnosis and treatment of Alzheimer’s disease: new definitions and challenges. 2020. Braz J Psychiatry. 2020; 42(4): 431-441.
[iii] Alzheimer’s Disease International. World Alzheimer Report 2021. Available at: https://www.alzint.org/u/World-Alzheimer-Report-2021.pdf Last accessed September 2024
[iv] Gustavsson A, Norton N, Fast T, et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer’s Dement. 2023;19(2):658-670. doi:10.1002/alz.12694.
[v] R.J. Jutten et al. A composite measure of cognitive and functional progression in Alzheimer’s disease: Design of the Capturing Changes in Cognition Study. Alzheimer’s & Dementia: Translational Research & Clinical Interventions 3.2017; 130-138.
[vi] Ritchie CW, Black CM, Khandker RK, et al. Quantifying the Diagnostic Pathway for Patients with Cognitive Impairment: Real-World Data from Seven European and North American Countries. J Alzheimers Dis. 2018;62(1):457-466. doi:10.3233/JAD-170864.
[vii] Eichler T, Thyrian JR, Hertel J, et al. Rates of formal diagnosis in people screened positive for dementia in primary care: results of the DelpHi-Trial. J Alzheimers Dis. 2014;42(2):451-458. doi:10.3233/JAD-140354.
[viii] Lee S.A.W., Sposato L.A., Hachinski V. et al. Cost-effectiveness of cerebrospinal biomarkers for the diagnosis of Alzheimer’s disease. Alz Res Therapy. 2017;9, 18.
[ix] Howe MD, et al. Clinical application of plasma P-tau217 to assess eligibility for amyloid-lowering immunotherapy in memory clinic patients with early Alzheimer's disease. Res Sq. 2024.
[x] Howe MD, et al. Clinical application of plasma P-tau217 to assess eligibility for amyloid-lowering immunotherapy in memory clinic patients with early Alzheimer's disease. Res Sq. 2024.
[xi] [POSTER] Vasileva, S et al. 2023. The diagnostic journey of patients with mild cognitive impairment and Alzheimer’s Disease Dementia, and the Importance of biomarker testing for timely Diagnosis: A real world survey in Europe.
[xii] EFIA. Unlocking the potential of precision medicine in Europe. Available at: https://www.efpia.eu/media/589727/unlocking-the-potential-of-precision-medicine-in-europe.pdf. Last accessed: July 2024.
[xiii] Angioni D, et al. Blood Biomarkers from Research Use to Clinical Practice: What Must Be Done? A Report from the EU/US CTAD Task Force. J Prev Alzheimers Dis. 2022;9(4):569-579.
[xiv] Inside Ageing. 2024. Opinion: Global survey reveals over 90% of people would seek a dementia diagnosis if they knew a drug treatment was available. Available at: https://insideageing.com.au/opinion-global-survey-reveals-over-90-of-people-would-seek-a-diagnosis-if-they-knew-a-drug-treatment-was-available/. Last accessed: September 2024.
