New biomarker in human postmortem brains at early AD stages by clinical validation in blood samples from patients in early stages with Mild Cognitive Impairment (MCI). An early diagnosis would facilitate a fast intervention with available drugs, promoting disease slowness, an improvement in patient’s quality of life, and a reduction of the direct and indirect costs for national health care systems and families.
- To develop cheap, fast and non-painful methods to be used in this first line of detection in primary care, hospitals and private medical assurances.
- Allow fast intervention to diminish the progression of the disease, improve patient’s quality of life and minimize associated direct and indirect cost for health systems and families.
Problem to Solve
More than 40 million people suffer Alzheimer’s disease (AD) worldwide. By now, there is no cure and the diagnosis occurs at advanced stages of the disease. Nowadays AD diagnostic is based almost exclusively in psychological tests once symptoms have been detected.
Only in a few cases a combined imaging techniques and cerebrospinal fluid sample analysis are performed as confirmation, which cost/patient is extremely high and are not exclusive for detecting AD. Therefore, there is a need of friendlier and cheaper diagnostic tools for early detection that would allow faster intervention on the disease progression.
The project is focused in the development of a new AD early detection kit, based on the new biomarker detection in blood analysis. An increase in the percentage of the biomarker in human postmortem brains from early stages of AD compared to healthy subjects has been identified.
MCI is considered an early AD stage, and MCI patients appear to be at an increased risk of developing AD at the rate of 10% to 15% per year versus 1-2% in old healthy people. There may be a difference in the biomarker presence between MCI patients that do not progress to AD and those that do, in combination with other currently recognised AD risk factors. If this hypothesis is verified, we may propose a new in vitro diagnostic tool for an early AD diagnosis.
Level of Innovation
Current gold standard treatments offers symptomatic efficacy in early stages but in later stages become largely ineffective. Indeed, drugs administered for some AD comorbidities, are demonstrated slight effects on delaying MCI progression to AD, but with no effect on AD once diagnosed.
AD disease therapies are mostly falling at late clinical stage studies and approvals are few, three in the last 10 years by the FDA. Therefore, biomarker tests are the new focus.
Blood-based assays for AD biomarkers hold great promise as screening tests that can be widely applied in a cost-effective manner, but results have been quite elusive until now. The only FDA-approved diagnostic assay for AD unfortunately is not exclusive of AD. There are a handful of diagnostic tools currently under development. If our early detection kit is being clinically validated, it will consist on a cheap analysis, based on a standard blood test representing a non-invasive technique.