A new multimillion pound study, which will see the most thorough and rigorous series of tests to detect Alzheimer's disease ever performed on volunteers, is announced today (Monday 22 August). The Deep and Frequent Phenotyping study is funded by the National Institute of Health Research and the MRC and hopes to dramatically improve the success rate of clinical trials for treatments in Alzheimer's disease.
This landmark £6.9million research project has been designed to identify measurable characteristics, known as biomarkers, which can detect the occurrence of Alzheimer's disease very early on in the progression of the disease - when a person may have no obvious symptoms.
Between 2002 and 2012, 99% of clinical trials into treatments for Alzheimer's disease failed. A probable reason for the high failure rate is that treatments are being tested on those who already have irreparable damage to the brain. It is likely that treatments will be more effective in slowing or stopping further at onset of dementia at earlier stages of the disease. Also, by targeting people in the earlier stages, it should be possible to design better clinical trials for treatments that make a real difference and improve people's lives.
The multisite team, led by the University of Oxford, will work with colleagues at eight UK universities and the Alzheimer’s Society, with the project also receiving support from a coalition of biopharma companies.
Together, the researchers will perform up to 50 tests on 250 volunteers from Dementias Platform UK cohorts, including new tests that have never been used before to detect dementia. The tests will include wearable devices that will give researchers detailed information on people's movement and gait, and sophisticated retinal imaging that will look at subtle changes affecting a person's central and peripheral vision.
These potential new biomarkers will be used alone and alongside tests such as brain imaging and assessment of memory and other cognitive functions. They will allow the researchers to recognise the early stages of the disease and those who may be suitable for trials of possible treatments.
We know that Alzheimer's disease starts long before it is noticed by those with the disease or their doctor. Previous studies have shown changes to the brain as early as 10 to 20 years before symptoms arise. If we can identify the biomarkers present in this very early stage, we have the chance of treating the disease earlier, which is vital if we are to prevent damage to people's memory and thinking.
Prof. Simon Lovestone, Department of Psychiatry
An estimated 46.8m people worldwide were living with dementia in 2015, and with an ageing population in most developed countries, predictions suggest this number may double by 2050. Currently, there is no known cure for the disease, and few treatments which are available treat symptoms of the disease, rather than slow or stop its progression.
Professor Simon Lovestone, lead researcher and Professor of Translational Neuroscience at the University of Oxford, said: 'We know that Alzheimer's disease starts long before it is noticed by those with the disease or their doctor. Previous studies have shown changes to the brain as early as 10 to 20 years before symptoms arise. If we can identify the biomarkers present in this very early stage, we have the chance of treating the disease earlier, which is vital if we are to prevent damage to people's memory and thinking. We're indebted to those volunteers taking part in the study whose time and effort will make a real difference to our ability to diagnosis and treat this disease.'
Dr Rob Buckle, director of science programmes at the MRC, said: 'This is the first major clinical study based on Dementias Platform UK and the results could be game changing for dementia research. Our goal is to find treatments that can slow down or even stop the progression of Alzheimer's disease. Finding biomarkers for clinical trials is crucial for fast-tracking decisions as to whether a trial should stop or continue, and the faster we can find out which drugs work and which ones don't, the faster we can benefit patients. An ability to deliver more cost-effective clinical trials would also encourage investment and increase the number of such studies in the future.'
Chief Scientific Adviser at the Department of Health, Professor Chris Whitty, said: 'By working together, the National Institute for Health Research and the Medical Research Council are leading the way on new and potentially important treatments for dementia. This important study will hopefully encourage more people to take part in our high quality research to help uncover more insight into causes and possible solutions for dementia.'
How the study will be run
The Deep and Frequent Phenotyping study will recruit 250 volunteers from existing study cohorts led by the Dementias Platform UK, and tests will be carried out over the course of 12 months.
Some of the participants will be at risk of developing Alzheimer's disease - due to their age, genes and performance in memory tests - and other participants will not be deemed at risk.
The tests will involve:
- Movement and walking (gait) assessments using wearable devices
- Ophthalmological assessments to photograph the back of the eye (the retina)
- Magnetic Resonance Imaging (MRI) brain scans using an MRI scanner to generate an electronic picture of the brain using magnetic fields instead of X-rays
- Magnetoencephalography (MEG) to measure the magnetic fields produced by nerve cells and electroencephalogram (EEG) brain scans to measure the electrical currents association with brain activity
- Positron emission tomography (PET) brain scans to detect build-up of proteins associated with Alzheimer's disease in the brain
- Thinking and memory (cognitive) assessments which will measure how well participants can pay attention, solve problems and remember things
- Clinical assessments including blood and urine samples and cerebrospinal fluid
The partners involved in the study are: University of Oxford, University of Cambridge, University College London, King's College London, West London Mental Health Trust/Imperial College London, Newcastle University, University of Manchester, University of Edinburgh, Cambridge Cognition, Imanova, Aridhia, Exprodo, Sage Bionetworks, TrialSpark, Optos, IXICO, Berry Consultants, AstraZeneca /MedImmune and the Alzheimer's Society.