Proteome Regulatory News (PRM)

Blood test for Alzheimer's moves considerably closer

8th July, 2014 - Cobham, UK: Proteome Sciences is pleased to announce publication of a study it has co-authored with King's College London in which a set of 10 proteins in the blood have been identified which can predict the onset of Alzheimer's disease. The study which analysed over 1,000 individuals is the largest of its kind to date and marks a significant step towards developing a blood test for the disease.

There are currently no effective long-lasting drug treatments for Alzheimer's, and it is believed that many new clinical trials fail because drugs are given too late in the disease process. A blood test could be used to identify patients in the early stages of memory loss for clinical trials to find drugs to halt the progression of the disease.

Secretary of State for Health, Jeremy Hunt, said: "This is welcome research on an issue we've made a national priority. Developing tests and biomarkers will be important steps forward in the global fight against dementia as we search for a cure."

The study, published today in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, is the result of an international collaboration led by King's College London and Proteome Sciences plc, funded by Alzheimer's Research UK, the UK Medical Research Council, the National Institute for Health Research (NIHR) Maudsley Biomedical Research Centre and Proteome Sciences.

The researchers used data from three international studies. Blood samples from a total of 1,148 individuals (476 with Alzheimer's disease; 220 with 'Mild Cognitive Impairment' (MCI) and 452 elderly controls without dementia) were analysed for 26 proteins previously shown to be associated with Alzheimer's disease. A sub-group of 476 individuals across all three groups also had an MRI brain scan.

Researchers identified 16 of these 26 proteins to be strongly associated with brain shrinkage in either MCI or Alzheimer's. They then ran a second series of tests to establish which of these proteins could predict the progression from MCI to Alzheimer's. They identified a combination of 10 proteins capable of predicting whether individuals with MCI would develop Alzheimer's disease within a year, with an accuracy of 87 percent.

Dr Abdul Hye, lead author of the study from the Institute of Psychiatry at King's College London, said: "Memory problems are very common, but the challenge is identifying who is likely to develop dementia. There are thousands of proteins in the blood, and this study is the culmination of many years' work identifying which ones are clinically relevant. We now have a set of 10 proteins that can predict whether someone with early symptoms of memory loss, or mild cognitive impairment, will develop Alzheimer's disease within a year, with a high level of accuracy."

Professor Simon Lovestone, senior author of the study from the University of Oxford, who led the work whilst at King's, said: "Alzheimer's begins to affect the brain many years before patients are diagnosed with the disease. Many of our drug trials fail because by the time patients are given the drugs, the brain has already been too severely affected. A simple blood test could help us identify patients at a much earlier stage to take part in new trials and hopefully develop treatments which could prevent the progression of the disease. The next step will be to validate our findings in further sample sets, to see if we can improve accuracy and reduce the risk of misdiagnosis, and to develop a reliable test suitable to be used by doctors."

Dr Eric Karran, Director of Research at Alzheimer's Research UK, the UK's leading dementia research charity, said: "As the onset of Alzheimer's is often slow and subtle, a blood test to identify those at high risk of the disease at an early stage would be of real value. Detecting the first signs of Alzheimer's could improve clinical trials for new treatments and help those already concerned about their memory, but we're not currently in a position to use such a test to screen the general population.

"With an ageing population, and age the biggest risk factor for Alzheimer's, we are expecting rising numbers of people to be affected over the coming years. It's important to develop new ways to intervene early in the disease to help people maintain their quality of life for as long as possible."

Dr Ian Pike, co-author of the paper from Proteome Sciences, said: "By linking the best British academic and commercial research, this landmark study in Alzheimer's disease is a major advance in the development of a simple blood test to identify the disease before clinical symptoms appear. This is the window that will offer the best chance of successful treatment. Equally important, a blood test will be considerably easier and less expensive than using brain imaging or cerebrospinal spinal fluid.

"We are in the process of selecting commercial partners to combine the protein biomarkers in a blood test for the global market, a key step forward to deliver effective and early treatment for this crippling disease."

Alzheimer's disease is the most common form of dementia. Globally, it is estimated that 135 million people will have dementia by 2050. In 2010, the annual global cost of dementia was estimated at $604 billion. MCI includes problems with day-to-day memory, language and attention, and can be an early sign of dementia, or a symptom of stress or anxiety. Approximately 10% of people diagnosed with MCI develop dementia within a year but apart from regular assessments to measure memory decline, there is currently no accurate way of predicting who will, or won't, develop dementia.

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Notes for editors:

About Proteome Sciences plc (www.proteomics.com)

Proteome Sciences is a global leader in applied proteomics and peptidomics offering high sensitivity, proprietary technologies for protein and peptide biomarker discovery, validation and assay development. The Company is headquartered in Cobham, UK, with laboratory facilities in London and Frankfurt.

Proteome Sciences has worked closely alongside King's College London (King's) for the last 12 years and undertakes proteomics discovery work using its leading edge technical expertise, equipment, bioinformatics, data analysis and infrastructure.

The Company was involved in the original identification and validation of protein and peptide biomarkers from blood in Alzheimer's disease (AD) with King's which were jointly published in a study in Brain in 2006 and it was from this research and the subsequent major sample set just completed that the 26 proteins were selected.

It has established a comprehensive range of biomarker assays and services in AD for the pharmaceutical industry as it switches programmes increasingly to tackle tau tangles in combination with beta amyloid plaques for the next generation of drugs and patient management. Biomarkers can also be used for increasing the speed and to reduce the cost of clinical trials, for patient stratification, drug development and testing and monitoring patient response.

The UK Prime Minister, David Cameron, recently endorsed the work of Proteome Sciences in his key note speech at the G8 Dementia Summit held in London in December 2013 by saying ""There is hope. I see it in the extraordinary work of UK life sciences companies like Proteome Sciences, working with others to develop new tests for Alzheimer's Disease."

Proteome Sciences' proprietary research has discovered a large number of novel protein biomarkers in key human diseases and is focused mainly in neurological/neurodegenerative conditions and in cancer. It has discovered and patented blood biomarkers in Alzheimer's disease, stroke, brain damage and lung cancer for diagnostic and treatment applications that are available for license or have already been outlicensed.

The Company's PS Biomarker Services division provides outsourced proteomics services and proprietary biomarker assays to pharmaceutical, biotechnology and diagnostics companies from its ISO 9001:2008 facility in Frankfurt, Germany.

Commercial exploitation rights to and associated patents for the AD biomarkers referred to in this press release are controlled by Proteome Sciences. A first license to use the AD biomarkers has been granted to Merck Millipore.

About King's College London (www.kcl.ac.uk):

King's College London is one of the top 20 universities in the world (2013/14 QS World University Rankings) and the fourth oldest in England. It is The Sunday Times 'Best University for Graduate Employment 2012/13'. King's has nearly 26,000 students (of whom more than 10,600 are graduate students) from some 140 countries worldwide, and more than 7,000 staff. The College is in the second phase of a £1 billion redevelopment programme which is transforming its estate.

King's has an outstanding reputation for providing world-class teaching and cutting-edge research. In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in the top quartile of British universities; over half of our academic staff work in departments that are in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College is in the top seven UK universities for research earnings and has an overall annual income of nearly £590 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King's fundraising campaign - World questions|King's answers - created to address some of the most pressing challenges facing humanity has reached its £500 million target 18 months ahead of schedule. The College is now aiming to build on this success and raise a further £100 million by the end of 2015, to fund vital research, deliver innovative new treatments and to support scholarships. The campaign's five priority areas are neuroscience and mental health, leadership and society, cancer, global power and children's health. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

About Alzheimer's Research UK:

Alzheimer's Research UK is the UK's leading charity specialising in finding preventions, treatments and a cure for dementia. Our Defeat Dementia campaign, a pledge to raise £100 million in five years to grow the research field and accelerate progress towards new treatments and preventions, was announced by the Prime Minister at the G8 legacy event on 19 June 2014. For more information visit www.dementiablog.org/defeat-dementia. To help us defeat dementia, donate today by visiting www.alzheimersresearchuk.org or calling 0300 111 5555. We are currently supporting dementia research projects worth over £22 million in leading Universities across the UK.

About the University of Oxford:

Oxford University's Medical Sciences Divisionis one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK's top-ranked medical school.

From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery.

A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions.