Whole-Blood Test Identifies Individuals at High Risk of Developing Full Alzheimer’s Disease

It's the leading cause of dementia, making up 60 to 80 percent of all dementia cases. Around the globe, someone is diagnosed with dementia every three seconds. The global cost of caring for dementia patients stood at USD 360 billion, a figure projected to hit USD 1 trillion by 2050 unless effective interventions are found. Given this backdrop, there is an increasing need for blood tests that can provide an early diagnosis of Alzheimer's and track its progression. Now, a new study has confirmed that a whole blood test can flag individuals at a high risk of developing full Alzheimer’s disease.

Initial findings from PharmaKure Limited (Manchester, UK), a pharmaceutical company spun out from The University of Manchester (Manchester, UK), indicate that the company’s innovative whole blood test, named ALZmetrix, can measure biomarkers related to Alzheimer’s to provide early warning of cognitive decline in patients with the disease. The study, which received ethical approval, was a blinded clinical trial focused on analyzing whole blood samples. Several biomarkers were examined to categorize individuals with Alzheimer’s who had been previously assessed for amyloid deposits either through brain PET scans or tests on cerebrospinal fluid (CSF). Biomarker protein levels were then recorded from the blood samples of patients in the initial stages of Alzheimer's.

The research aimed to find out if the presence of amyloid deposits in the brain could be accurately detected through this test. It also sought to assess how far along patients were on the road to full-blown Alzheimer's. Machine learning algorithms were utilized to optimally combine blood biomarker data with patient information to establish predictive markers. The study confirmed that the use of whole blood, as opposed to just blood plasma, can successfully identify individuals at elevated risk of fully developing Alzheimer’s disease. Furthermore, the machine learning tools highlighted which biomarkers were most effective for this identification.

Compared to expensive and often uncomfortable PET brain scans or CSF collections, a simple blood test like ALZmetrix could offer a simpler, yet accurate, alternative. One major benefit of using whole blood is the potential for creating a screening system that can detect Alzheimer’s even before significant memory issues manifest. Early detection would pave the way for timely treatments, improve health outcomes at a population level, and reduce the burden on healthcare systems. It would also enhance the life quality for millions affected by the disease. PharmaKure plans to conduct a more extensive study, involving an independent lab to corroborate these findings, before seeking the necessary regulatory approvals to introduce the test to the market.

“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,” 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.”

“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,” said Dr Farid Khan, 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.”

“Using the ALZmetrix test for Alzheimer’s 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,” added Dr. Bob Smith, Clinical Director at PharmaKure.

Related Links:
PharmaKure Limited
The University of Manchester