The completion of a large-scale biomarker validation study led by Proteome Sciences is a “major step” towards developing a series of simple blood tests that would facilitate early diagnosis and management of Alzheimer’s disease (AD), both in clinical trials and clinical practice, the company says.

Working with the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) for Mental Health and with Merck Millipore, Proteome Sciences analysed more than 40 protein biomarkers in 1,000 individuals compromising patients with a clinical diagnosis of mild-to-moderate Alzheimer’s disease or mild cognitive impairment as well as appropriate age- and sex-matched controls.

Levels of each blood protein were compared with more than 200 different clinical parameters to determine which proteins were most effective at making an early diagnosis of AD, predicting the current duration of disease and plotting the likely future course of cognitive decline.

Three panels

So far, three biomarker panels that can discriminate between mild cognitive impairment (often a precursor of AD), Alzheimer’s disease and control groups respectively have been identified. Each panel contains between 11 and 16 proteins.

“We will move quickly to support the development of clinical tests based on these biomarker panels,” 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 in, London.

Proteome Sciences, a UK-based specialist in applied proteomics and peptidomics for protein and peptide biomarker discovery, validation and assay development, is filing additional intellectual property around the panels, which include and combine markers covered by existing patents with additional newly validated biomarkers.  

More to come

Given the complexity of the data presented at RASAD 2012 (the Research and Standardisation in Alzheimer’s Disease conference) in Melbourne, Australia, “we expect that the full analysis will introduce further biomarkers to the three panels announced today over the coming months”, commented Christopher Pearce, chief executive officer of Proteome Sciences.  

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 company notes, adding: “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”.

Presenting the study data at RASAD 2012, Professor Lovestone commented: “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”.