Healthcare (Commonwealth Union) – A new national clinical trial has been launched in the UK with the ambition of cutting years from the search for treatments for the most common form of dementia, Alzheimer’s disease.
The trial, AD-SMART, is led by the UK Dementia Research Institute (UK DRI) at Imperial College London and the charity Alzheimer’s Research UK. It is run in partnership with the National Institute for Health and Care Research, the Medical Research Council and Health Data Research UK and UK government has pledged ongoing funding. Health minister Alison McGovern attended the launch at the trial site at Charing Cross Hospital in London on 21 October, meeting the research team and a participant.
A growing problem with few solutions
Alzheimer’s affects some 600,000 people in the UK. More broadly, nearly a million people nationally are living with dementia. That number is expected to increase to 1.4 million by 2040, according to the Alzheimer’s Society.
How the trial works.
Traditionally, testing a dementia drug has meant running one trial for one medicine, a process that can take a decade or more to produce an answer. AD-SMART does this a different way, by using ideas that have been used already for cancer and other diseases.
The name is an acronym for Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial. In layman’s terms – multiple drugs are tested simultaneously with each drug given to a different group of volunteers. Unusually, each group is compared to a single group of people who take a placebo, a dummy treatment which has no active ingredient.
Researchers will study whether the medicines can alleviate symptoms such as memory and thinking problems, and whether they help people preserve their quality of life as the disease progresses.
The results are checked at regular intervals. If a drug is not showing a clear benefit, it can be quickly dropped and substituted with another candidate. This means that fewer people waste their time on treatments that ultimately don’t work, and more overall participants receive an active drug than in a conventional trial. A common placebo group has also the ability to reduce the time to analyse treatments by more than half, which is more economical.
The trial will start with two drugs already approved for other conditions, one for type 2 diabetes and another for attention deficit hyperactivity disorder (ADHD).
These drugs are already in use and thus well understood for safety. If it fights Alzheimer’s, it may reach patients far more quickly than a brand-new medicine developed from scratch. The trial will also test new potential treatments as they emerge from the research pipeline, and drug companies will have the opportunity to bring their own candidates directly into the trial.
The study lead Professor Paresh Malhotra, at Imperial College London indicated that Alzheimer’s research has been far too slow for far too long, with only one drug being tested at a time and answers sometimes taking more than ten years. He indicated that they hope they can accelerate things by applying advances made in other fields.
Prime Minister Andy Burnham indicated that he was proud to see the trial begin in the UK. He said he had made research into dementia a national priority and wanted Britain to lead the way in breakthroughs.
Science Minister Chris McDonald said the trial could help discover new treatments faster by investigating how existing drugs could be used against dementia, giving hope of improved quality of life for patients in the future.
“Time is of the essence for people living with the disease, said Dr Sheona Scales, Director of Research at Alzheimer’s Research UK. “There is a pressing need for more options to help people live well for longer and stay connected to the ones they love,” she said.
Who is delivering
The trial is being run by Imperial and the UCL Innovative Clinical Trials Unit and MRC Center of Research Excellence in Clinical Trial Innovation at University College London, the University of Oxford, and Dementias Platform UK, with input from Alzheimer’s experts across the country.
