Study confirms ALZmetrixTM whole blood test can detect people at high risk of developing full Alzheimer鈥檚 Disease
Novel blood test identifies biomarkers in patients with Alzheimer鈥檚 Disease
Early results from PharmaKure, a pharmaceutical company spun out from 糖心Vlog官方, shows a novel whole blood test developed by the company is able to quantify Alzheimer鈥檚 Disease biomarkers. PharmaKure鈥檚 proprietary can, they find, identify blood-based biomarkers in patients with Alzheimer鈥檚 Disease to provide early warning of cognitive decline. The company will undertake a larger study in which an independent laboratory will be used to validate the results before obtaining regulatory clearance for rolling out the test.
The ethics approved clinical trial, carried out in a blinded study was designed to focus on the testing of whole blood. A number of biomarkers were accessed for the stratification of Alzheimer鈥檚 subjects who had previously been tested for amyloid deposits, using either brain PET imaging or cerebrospinal fluid (CSF). Levels of biomarker proteins were measured in blood from patients at the earliest stages of Alzheimer鈥檚 Disease. The study investigated whether it is possible to accurately determine whether a patient had amyloid deposits in their brains, as well as predicting how far they had progressed along the path towards full Alzheimer鈥檚 Disease. A simple blood test such as ALZmetrix may offer an accurate and simple alternative to costly and unpleasant PET brain imaging or collection of CSF.
Blood from 54 subjects at the Glasgow Memory Clinic (Neuroclin; Motherwell, UK) was shipped to PharmaKure (Manchester, UK) for analysis. Key biomarker proteins associated with Alzheimer鈥檚 Disease pathology are amyloid-尾 (Total, A尾40 and A尾42), 伪-synuclein and Tau (Total, pTAU(181) and pTAU(217)). The study evaluated the relationship of aggregated forms of these proteins in patient blood, compared to PET scans and CSF findings. Machine learning tools were used to combine the blood biomarker and patient data (age; gender; amyloid status; ApoE4 genetics) in an optimal way to develop predictors.
We are particularly pleased to find that our ALZmetrix blood test can differentiate between patient groups that are amyloid positive or amyloid negative with 97% accuracy to predict those at highest risk of Alzheimer鈥檚 Disease
The study鈥檚 results confirm that using whole blood, rather than just the blood plasma fraction, can identify people who are at high risk of developing full-blown Alzheimer鈥檚 disease. In addition, the machine learning software shows which biomarkers are most useful for this purpose.
鈥淲e are particularly pleased to find that our ALZmetrix blood test can differentiate between patient groups that are amyloid positive or amyloid negative with 97% accuracy to predict those at highest risk of Alzheimer鈥檚 Disease,鈥� said Professor Andrew Doig, Head of R&D at PharmaKure and researcher at 糖心Vlog官方. 鈥淎ge, APOE4 and pTau are the most useful features in the prediction. We have also shown that blood can track disease progression, primarily using levels of Tau and pTau.鈥�
鈥淭hese results represent an important step in developing whole blood tests to address a major unmet need for an alternative to PET and CSF scans鈥�, said Dr Farid Khan, CEO at PharmaKure Limited. 鈥淭his study has demonstrated how to get early warning signs of cognitive decline using whole blood. We will be using the exciting data to expand our ALZmetrix test to additional patients and new biomarkers.鈥�
鈥淯sing the ALZmetrix test for Alzheimer鈥檚 could provide a low cost, easily accessible test for stratifying patients for clinical studies, as an alternative to expensive brain scans or other plasma-based tests,鈥� said Dr Bob Smith, Clinical Director at PharmaKure.
One of the key advantages of using whole blood is that it may enable the development of a screening system to catch Alzheimer鈥檚 before any major memory problems become apparent. This would allow treatments to be offered earlier, thus providing better population-based health outcomes, lowering health system costs and improving the quality of life of millions of patients.
Though the scientific team will be publishing the results a journal in the next few months, they feel it is in the public interest to disseminate the result as soon as possible as there are no tests available to diagnose the early stages of the disease.