PharmaKure, a pharmaceutical company spun out from the University of Manchester, announced successful study results for a novel whole-blood test for quantifying Alzheimer’s Disease biomarkers.
PharmaKure’s proprietary ALZmetrix blood test can identify blood-based biomarkers in patients with Alzheimer’s Disease to provide early warning of cognitive decline, according to the company.
Novel Whole-Blood Test
The study was designed to focus on the testing of whole blood. A number of biomarkers were accessed for the stratification of Alzheimer’s 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’s 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’s 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, according to the company.
Data from the Study
Blood from 54 subjects at the Glasgow Memory Clinic was shipped to PharmaKure for analysis. Key biomarker proteins associated with Alzheimer’s Disease pathology are amyloid-β (Total, Aβ40 and Aβ42), α-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.
The study’s 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’s disease. In addition, the machine learning software shows which biomarkers are most useful for this purpose.
“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’s Disease,” says Professor Andrew Doig, head of R&D at PharmaKure. “Age, 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.”
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One of the key advantages of using whole blood is that it may enable the development of a screening system to catch Alzheimer’s before any major memory problems become apparent, the company says. 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.
“These results represent an important step in developing whole blood tests to address a major unmet need for an alternative to PET and CSF scans”, says Farid Khan, PhD, CEO at PharmaKure Limited. “This 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.”