PreADx's Stakeholder Groups are:
1) pharmaceutical and nutraceutical companies plus R&D groups dedicated to developing new AD therapies,
2) physicians and caregivers bringing those to practice in public and private hospitals, and nursing homes
3) AD patients, their families and society in general and citizens looking for early diagnosis
4) healthcare system in general.
In detail, for Stakeholder Group 1, there is 99% attrition rate of human-tested compounds targeting AD failing to reach the market; among the highest in any therapeutic area . Thus, R&D efforts are currently shifting to better understanding the disease progression and possibly target early disease mechanisms to delay the onset of the disease. In these studies, repeated CSF analysis or PET imaging are not applicable due to high cost and low compliance, and thus a blood-based test is ideally suited– which is driving pharm players to strongly seek for cost-effective methods for patient selection and follow-up of therapeutic interventions. Lastly, US Food and Drug Administration released a new guidance document earlier in 2018 highlighting the importance of biomarkers in early AD studies.
For Stakeholder Group 2, time-limited improvement of cognitive function from current therapies underlines the near impossibility of counteracting irreversible brain damage. Current routine diagnostics of AD takes 6-12 months and only begins after the first symptoms appear, due to prohibitive costs of screening. Quick and affordable tests can capture the disease progress early in a screening routine and delay the disease progression.
For Stakeholder Group 3, there is a very high demand for early diagnosis, even if no real efficacious drugs for AD available now. Early and reliable diagnosis will allow to prepare the senior’s life plan, which is the key concern for individuals and their families.
For Stakeholder Group 4, reduction of costs associated with AD is of high importance. Indeed, AD’s Costs to Society were estimated by Alzheimer’s Europe at staggering €177Bn already in 2008; the corresponding costs in the USA were estimated at €167Bn.
This stems from the fact that as of 2013, according to Alzheimer’s Europe, estimated 8.7Mn people living with AD in Europe. Further, according to World Alzheimer’s Report 2015, 46.8Mn are living with dementia worldwide, with a staggering nearly three-fold prevalence increase until 2050.
In addition, AD is the top health condition responsible for overall prevalence of both disability and dependence in the elder population, as the onset of cognitive impairment quickly compromises their ability to carry out complex but essential. Moreover, AD’s progression quickly escalates the need for care, accelerating the costs and the economic burden of the disease – above and beyond other leading diseases such as stroke, heart disease and cancer, both in EU and in the USA .
