Proteome Sciences, in collaboration with the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health and Merck Millipore, has completed its 1,000-sample Alzheimer’s disease (AD) biomarker validation study.

Preliminary results indicate that these biomarkers have significant potential diagnostic and prognostic utility that could form the basis of a series of simple blood tests for the diagnosis and management of this debilitating disease. Three biomarker panels in blood, each containing between 11 and 16 proteins, have been identified that can discriminate between mild cognitive impairment (a syndrome often preceding AD), AD and control groups, respectively. Proteome Sciences is filing further intellectual property around these panels, which include and combine markers covered by existing patents with additional newly validated biomarkers.

It is currently estimated that 60% of people with AD have not been properly diagnosed and therefore are not being given vital drugs and care. The capability to distinguish between the levels and progression of the disease will enable drug developers to substantially improve patient care, and people with mild cognitive impairment are likely to benefit the most from such disease-modifying drugs.

Currently AD biomarker and diagnostic development involves either cerebrospinal fluid (CSF) measurements, which requires invasive lumbar punctures, or brain imaging via magnetic resonance imaging (MRI). Neither of these approaches is well-suited for use outside clinical trials. In contrast, commercialization of a diagnostic based on plasma biomarkers would provide a screening approach for the disease.

“These results represent the largest study of plasma biomarkers to date, that we are aware of, and confirm our earlier findings that there are valuable diagnostic and prognostic signals in plasma,” said Professor Simon Lovestone, director of the NIHR BRC for Mental Health and director of research at King’s Health Partners Academic Health Sciences Centre, London. “As new treatments for Alzheimer's disease are being developed, there is an increasing need for accurate and accessible markers of disease severity and progression. We will move quickly to support the development of clinical tests based on these biomarker panels.”

Christopher Pearce, CEO of Proteome Sciences, said, “This study is a major step toward a series of simple blood tests that would facilitate the early diagnosis and management of Alzheimer’s. Such tests will address a major unmet need and will have widespread application and commercial value. Our analysis of the data from this large study provides individual markers and defined marker panels that have good diagnostic and prognostic utility. Given the complexity of the data, we expect that the full analysis will introduce further biomarkers to the three panels over the coming months and we are hopeful that collectively these will benefit patients and families suffering from the devastating effects of Alzheimer’s.”