PharmaKure, a pharmaceutical company stemming from The University of Manchester, has unveiled preliminary findings indicating the success of a groundbreaking whole blood test for quantifying Alzheimer’s disease biomarkers.
The proprietary ALZmetrix™ blood test has shown the ability to identify blood-based biomarkers associated with Alzheimer’s disease, potentially providing early warnings of cognitive decline.
PharmaKure intends to conduct a larger study with independent validation before seeking regulatory approval for widespread use.
The Clinical Trial
This ethical clinical trial was carried out in a blinded manner and focused on whole blood testing.
Researchers aimed to stratify subjects with Alzheimer’s disease who had previously undergone testing for amyloid deposits, using either brain PET imaging or cerebrospinal fluid (CSF).
The study evaluated whether it was possible to accurately determine the presence of amyloid deposits in the brain and predict the progression toward full Alzheimer’s disease.
ALZmetrix aims to offer a simpler, less costly alternative to PET brain imaging or CSF collection.
Blood samples from 54 subjects at the Glasgow Memory Clinic were sent to PharmaKure for analysis.
The study examined key biomarker proteins associated with Alzheimer’s disease pathology, including amyloid-β (Total, Aβ40, and Aβ42), α-synuclein, and Tau (Total, pTAU(181), and pTAU(217)).
Machine learning tools were employed to combine blood biomarker data with patient information (age, gender, amyloid status, ApoE4 genetics) to develop predictors.
The study’s findings indicate that using whole blood, rather than just the blood plasma fraction, can effectively identify individuals at a high risk of developing full-blown Alzheimer’s disease.
Furthermore, machine learning analysis identified which biomarkers are most valuable 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 the highest risk of Alzheimer’s disease,” said Professor Andrew Doig, Head of R&D at PharmaKure and researcher at The University of Manchester.
“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.”
The ALZmetrix blood test offers the potential for cost-effective and easily accessible Alzheimer’s disease screening.
It could serve as a means to stratify patients for clinical studies, providing an alternative to expensive brain scans or other plasma-based tests.
Detecting Alzheimer’s disease in its early stages may enable early interventions and improve health outcomes, reduce healthcare costs, and enhance the quality of life for numerous patients.
The scientific team plans to publish the results in a journal in the coming months but believes that disseminating the findings promptly serves the public interest, as there are currently no tests available for diagnosing the early stages of the disease.
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