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The Innovative Medicines Initiative (IMI) is launching a major new project that will pioneer a novel, more flexible approach to clinical trials of drugs designed to prevent Alzheimer's disease. The €53 million project, which will see several biotechnology and pharmaceutical companies working closely together, will aim to speed up drug development and patient access to the latest treatments. The announcement comes as the UK hosts a G8 summit dedicated to dementia in London on 11 December.
There is an urgent need for new treatments for Alzheimer's disease. The number of people affected worldwide is expected to reach 100 million by 2050, yet despite intensive efforts over many years, there is still no cure for Alzheimer's and little in the way of treatments.
The new project will focus its efforts on improving the system of 'proof of concept' studies, early stage clinical trials in which researchers seek to determine if a candidate drug is safe and has an impact on the disease in humans. Currently, companies carry out these trials individually. Each trial costs a lot of money, lasts several years, and may require thousands of patients, half of whom are treated with a placebo.
The new project will test a new way of running these proof of concept trials, in which several candidate drugs are simultaneously compared to a placebo. In this scenario, only about 20% of patients are in the placebo group, compared to 50% in conventional trials. Furthermore, this novel 'adaptive' trial design allows researchers to adapt the trial design in response to emerging results. For example, if a candidate medicine appears to be particularly effective in only certain categories of people, then assignment of that medicine can be preferentially directed to those people to confirm this finding. Similarly, new candidate drugs can be added to the trial and medicines that prove ineffective can be dropped. In addition, this design allows researchers to test both individual drugs and combinations of different medicines.
This innovative trial design has already been found to be effective for testing new treatments for breast cancer. This will be the first time such an approach will be used for Alzheimer's disease.
Speaking in advance of the G8 summit on dementia, Michel Goldman, IMI Executive Director commented: 'The challenge of developing new treatments for Alzheimer's disease is too great for any single organisation, country or company to tackle alone. What is needed is an unprecedented, international, collaborative approach bringing together all stakeholders involved in the development of new treatments for Alzheimer's. As a public-private partnership experienced in running large-scale projects of this nature, IMI is the ideal platform to launch this new project that will hopefully deliver immense benefits for patients.'
The Alzheimer's project forms part of IMI's 11th Call for proposals, which is being launched in mid-December 2013 and gives researchers and experts from academia, small businesses, regulatory authorities, and patient organisations the opportunity to apply to be part of exciting new projects in a range of fields.
The project has a proposed budget of €53 million, €28 million of which comes from the European Commission's Seventh Framework for Research (FP7), and €25 million of which comes from in kind contributions by the pharmaceutical companies participating in the project.
'Today, advances in science and technology provide unprecedented opportunities to unlock the mysteries of Alzheimer's disease - including predisposing risk factors and early diagnosis to identify at-risk patients,' said Paul Stoffels, J&J Chief Scientific Officer and WW Chairman Janssen. 'The societal impact of this disease is enormous, and it will require unprecedented innovation and collaborative models between industry, academia and government to create better therapies and new models of patient care. We are proud to be part of this initiative, which advances our shared goal of better outcomes for patients and their loved ones.'
Researchers have long hunted for the holy grail of a drug that stops Alzheimer's in its tracks and even reverses some of the brain changes, yet the results of recent clinical trials have been disappointing. IMI's Pharma-Cog project is working to address some of the biggest challenges hampering the development of new Alzheimer's drugs, including the need for better tests to determine the efficacy of new drugs.
The working hypothesis of Pharma-Cog is that no single physiological, functional or biochemical marker will be sensitive enough to respond to a drug sufficiently to provide drug developers with the data they need to move on to more advanced clinical studies. Rather, a collection or 'matrix' of markers is necessary, and this is exactly what the Pharma-Cog team has developed. The Pharma-Cog matrix represents a unique tool for the study of Alzheimer's disease and potential treatments, as it can be applied to laboratory models, human volunteers and patients alike.
Earlier in 2013, the project completed the recruitment of 150 patients with mild cognitive impairment for a clinical trial of the Pharma-Cog matrix. The trial will help the Pharma-Cog team to test and reach conclusions on the value of the matrix as a tool for tracking disease progression in people with mild cognitive impairment.
Pharma-Cog Project Coordinator Dr Jill C. Richardson, Director, External Alliances and Development, R&D China at GlaxoSmithKline says: 'We believe the application of a multidimensional matrix to detect early disease and its response to novel drugs will reduce attrition in Phase III studies, which will speed up the development of crucially needed new treatments for this devastating disease.'
Pharma-Cog Academic Lead Regis Bordet, Departement de Pharmacologie, CHU de Lille et Université Lille 2, says: 'The outcomes of the Pharma-Cog project should pave the way for delivering new drugs that will improve patients' cognitive and behavioural symptoms and slow the progression of the disease. This should also reduce the economic and social burden of the disease.'
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There have been many different studies on Alzheimer's disease, and there is a huge volume of data available, but little of it is linked together, which makes it hard to use it to draw any useful conclusions. The aim of EMIF-AD, which was launched in early 2013, is to connect data from a variety of sources such as patient health records, research cohorts, biobanks, registries, epidemiology studies and biomarker research, including drug and disease history, test results, and gene sequencing. EFMI-AD is part of a wider project called EMIF (European Medical Information Framework), which has access to around 48 million patient records from 7 different countries.
Academic Lead for EMIF, Professor Simon Lovestone, PhD, MRCPsych, Professor of Old Age Psychiatry and Director of NIHR Biomedical Research Centre for Mental Health at the Maudsley and King's College London, says: 'As part of the EMIF-AD project, we plan to analyse millions of patients' records to find links between genes, biomarkers, disease and outcome. By reusing existing data, rather than having to generate new information, we can move forward more quickly.'
Because EMIF-AD brings together data from many patients and many sources, the first step will be to reassure the data 'owners' that the data will be used responsibly and appropriately. The next step is to work out how to structure, analyse and harmonise the data, which will be a challenge, but the project has brought together some highly skilled researchers from across Europe.
EMIF Project Coordinator Bart Vannieuwenhuyse, Senior Director Health Information Sciences at Janssen Pharmaceutica NV, says: 'The EMIF research teams include people from three independent research consortia and a range of different disciplines. We are looking forward to working with academic and industry scientists with such a range of different areas of expertise.' Alzheimer's disease can be present for 10 to 20 years before the symptoms emerge, but it's hard to predict who will develop this devastating disease. By delving into the EMIF-AD data, researchers hope to find biomarkers for early onset disease to identify the people who are at risk.
These patients could then be invited to join clinical trials to see if it's possible to prevent, or at least slow, the onset of the disease. Once these potential drugs have reached the market, the same markers could be used for early diagnosis and treatment, picking the patients who are most likely to benefit.
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Today, diseases are defined largely on the basis of the patient's symptoms and where it occurs in the body. Many are classified based simply on the name of the doctor or researcher who first discovered or described the disease - this is the case for both Alzheimer's and Parkinson's diseases. The conventional classification system is also rather rigid and it is not easy to adapt the classifications in response to new knowledge.
However, there is growing evidence that while two patients may be classified as having the same disease, the genetic or molecular causes of their symptoms may be very different. This means that a treatment that works in one patient will prove ineffective in another.
There is now broad recognition that the way diseases are classified needs to change, and the immense scale of the challenge means that only a large public-private partnership could take this on.
IMI's new AETIONOMY project will embark on a new approach to disease classification, with a focus on neurodegenerative conditions, particularly Alzheimer's diseases and Parkinson's disease. There is still little agreement on how these diseases should be reclassified with regard to the disease pathology, and in fact most cases are classified as 'idiopathic', i.e. their causes are not known.
Nevertheless, the literature, public databases, and private companies have vast amounts of data that could be used to pave the way for a better classification of patients. However we lack an efficient way to generate new knowledge from these resources. The AETIONOMY project will tackle the problem of how to dynamically organise and structure different types of data, from molecular data to information on symptoms, and how to apply this knowledge to construct a classification of patient groups based on the underlying causes of their disease.
The new project will deliver data, tools and recommendations that can be used by the biomedical community to develop new treatments and diagnostic tests.
The project is the result of IMI's 8th Call for proposals, and will be launched in January 2014.
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Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Initiative, Innovative Medicines. "New IMI project to revolutionise clinical trials for Alzheimer's drugs." Medical News Today. MediLexicon, Intl., 11 Dec. 2013. Web.
11 Mar. 2014. <http://www.medicalnewstoday.com/releases/269981>
Initiative, I. (2013, December 11). "New IMI project to revolutionise clinical trials for Alzheimer's drugs." Medical News Today. Retrieved from
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