The Need: Alzheimer’s Disease (AD) is a global pandemic, representing a €300 bn yearly expenditure in EU and affecting ~10% of its population above 65 years old. However, it has been estimated that a five-year delay in the disease onset could reduce the disease prevalence – and its costs – by up to 33% over the next decades, representing potential savings over €100 bn in EU alone. The disease progression could be delayed by combining compounds to block the initial stages of the neurodegenerative cascade and by lifestyle adjustments; however, current drug pipeline does not trigger sizeable improvements in AD patients. This is primarily due to irreversible brain damage in later AD stages.
Over 2,000 various AD interventions have been or are being tested in the World according to clinicaltrials.gov, around 600 of those in Europe, to compete in a growing, €2Bn market. But how to test the if those interventions are working in a quick, reliable and cost-efficient way? How to effectively select the patient cohorts for the tests? Therefore, the need for early diagnosis before symptoms arises become apparent, both to delay AD progression and to test the large pipeline of potential breakthrough medications. Despite the high need for early diagnosis, only 36 trials for AD detection are registered at clinicaltrials.gov. Will any of these work? Are they cost-effective?
Recent announcements on positive phase 3 results by Biogen provides compelling evidence to further support the amyloid hypothesis as a therapeutic target for Alzheimer’s disease. The recent progress within drug development triggers an increased demand for better diagnostic tools. Currently, the detection options are cerebral fluid test (detects beta-amyloid (Aß) – a neurotoxic metabolite that is the initiator of AD’s neurodegenerative cascade, as well as Tau and pTau biomarkers; it is invasive and costs around €5,000) and PET imaging (detects Aß plaques, relies on radioactive isotope injection and costs around €3,000). Both tests show amyloid burden which is not well correlated with the clinical symptoms. These are not suitable for mass screening and are therefore used when AD has progressed.