The AD-SMART trial, led by the UK Dementia Research Institute (UK DRI) at Imperial College London and Alzheimer’s Research UK, aims to significantly reduce the time it takes to find treatments that work for people with Alzheimer’s disease, the most common form of dementia. The trial was officially launched with a visit from Minister of State for Health and Social Care Alison McGovern MP to the trial site.
Currently, there are no NHS treatments that can slow or stop the underlying disease, which affects around 600,000 people in the UK. This new trial adopts a systematic multi-arm adaptive randomised trial approach, testing multiple drugs simultaneously against a single placebo group. This method, adapted from advances in cancer research, allows for faster identification of effective treatments.
The trial will begin by testing two repurposed medicines, already approved for type 2 diabetes and attention deficit hyperactivity disorder (ADHD). Their established safety profiles mean that if successful, they could be made available to Alzheimer's patients much more quickly than newly developed drugs. The design also allows for new potential treatments to be introduced as they become available.
Professor Paresh Malhotra, Study lead and Group Leader at the UK DRI Centre for Care Research & Technology at Imperial College London, stated, “For too long, Alzheimer’s research has moved at the pace of one drug, one trial, one answer, sometimes taking a decade or more before we know if we’ve found something that works. We are applying advances from cancer and other conditions to accelerate testing of treatments for people with Alzheimer’s disease.”
Professor Siddharthan Chandran, Director of the UK Dementia Research Institute, highlighted the success of the SMART approach in Motor Neurone Disease trials, stating, “We already know this model works. The SMART approach… has shown that testing multiple drugs at once, in one smart trial design, can speed up the testing of new treatments for neurodegenerative conditions. Now, we’re doing the same for Alzheimer’s.” The trial design also facilitates the inclusion of drugs from biotech and pharmaceutical companies.
Dementia is a significant medical and societal challenge, projected to affect 1.4 million people in the UK by 2040. UK Prime Minister Andy Burnham MP, whose father battled Alzheimer's, expressed his pride in the trial, stating, “I have made dementia research a national priority. I want Britain to be the leading nation, making the breakthroughs that change people’s lives.” UK Science Minister Chris McDonald MP added that the trial “will help to uncover new treatments faster by exploring how existing drugs might be used to treat dementia.”
The AD-SMART trial is designed to maximise the number of participants receiving active treatment by sharing a single placebo group, potentially halving evaluation time and reducing costs. Results will be reviewed regularly, allowing ineffective drugs to be dropped and replaced. The trial is delivered by a collaborative team from Imperial College London, UCL, the MRC, the University of Oxford, and Dementias Platform UK (DPUK).
