The national trial is called AD-SMART (Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial).
It is led by the UK Dementia Research Institute (UK DRI) and Alzheimer’s Research UK (ARUK).
The trial is in partnership with the National Institute for Health and Care Research, the Medical Research Council (MRC) and Health Data Research UK.
It has ongoing funding committed by UK government to support the trial.
Repurposing medicines
It will test multiple drugs simultaneously, starting with two repurposed medicines already used to treat type 2 diabetes and attention deficit hyperactivity disorder.
Groups of participants will each begin treatment with a different drug.
The study will examine whether these medicines can lessen symptoms such as memory and thinking problems, and help people maintain their quality-of-life as the disease progresses.
Testing drugs that are already approved to treat other conditions and known to be safe means that, if successful, treatments can reach people living with Alzheimer’s much faster than a medicine developed from scratch.
Testing new treatments
As well as repurposed drugs, the trial is designed to test new potential treatments coming through the research pipeline.
Heather Ransome, 67, from the Isle of Wight, was diagnosed with Alzheimer’s in 2024. She said:
Before my diagnosis, my partner and I were going on lots of cruises and coach holidays, enjoying retirement together.
We still enjoy life, but I’m worried about my condition getting worse.
I’m not the sort of person who gets upset, but being told you have Alzheimer’s is quite upsetting.
There weren’t many treatment options available, and the one drug I was offered has been around for many years.
Getting involved with AD-SMART has given me some hope for the future. It’s not too taxing, just some extra tablets to take every day.
I don’t know whether I’m being given the active treatment, but if it helps me, or helps others in future, that feels positive.
I would encourage anyone who thinks they might be eligible to sign up and speak to the team.
Dementia research: a national priority
The Prime Minister Andy Burnham said:
I know how it feels to lose a loved one to dementia and have seen first-hand the devastating impact this illness has on families.
That’s why I’m proud to see this trial being launched in the UK, so that cutting edge treatments can reach patients here as soon as possible.
I have made dementia research a national priority. I want Britain to be the leading nation, making the breakthroughs that change people’s lives.
Reducing time and cost
AD-SMART is a type of trial known as a multi-arm, multi-stage platform trial.
Several drugs are tested at the same time, and the results compared with one group of participants taking a dummy drug (placebo).
This means more people receive an active treatment than would in a traditional trial.
Results are checked at regular stages throughout the trial and any drug that isn’t showing benefit can be dropped quickly, with new drugs added in its place.
Overall, this means fewer participants end up receiving ineffective drugs.
Testing several drugs against one shared placebo group means that compared with a traditional trial, the time to evaluate treatments can be more than halved, which also reduces costs.
The trial is being delivered by:
- a team at Imperial College London
- the UCL Innovative Clinical Trials Unit and the MRC Centre of Research Excellence in Clinical Trial Innovation (UCL)
- the University of Oxford
- Dementias Platform UK
Leading Alzheimer’s experts from across the UK will be providing support.
Accelerating the testing of treatments
Chief Investigator, Professor Paresh Malhotra, Group Leader at the UK Dementia Research Institute (UK DRI) Centre for Care Research and Technology at Imperial College London, said:
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.
The way AD-SMART is set up means we’re testing several treatments at the same time, and those that don’t show promise can be quickly stopped.
Then we can start testing something else. That’s the best way to get effective treatments to patients as quickly as we can.
The first trials
The first trial participants have been recruited at Cambridgeshire and Peterborough NHS Foundation Trust and Surrey and Borders Partnership NHS Foundation Trust.
Sites based at Imperial College Healthcare NHS Trust, Edinburgh and Southampton are also now open.
Up to 20 NHS sites are expected to open across the UK over the next 12 to 18 months and more than 30 are planned overall.
Researchers aim to recruit 1,200 participants across the UK to test these first two drugs.
They expect to finish evaluating the first drugs in 2030, in around four years’ time.
During this initial four-year period, the team expect additional drugs to be added into the trial for testing.
Proven model
AD-SMART is the first trial of this kind for people living with Alzheimer’s, but the model has already proven itself in the UK.
MND-SMART, a similar platform trial for motor neuron disease, also led by the UK DRI, concluded that its first drugs tested were ineffective in just over three years.
This process would normally take at least eight years.
The trial has now moved on to testing other promising drugs.
Accelerating progress in health research
MRC Executive Chair Professor Patrick Chinnery said:
Innovative clinical trials like AD-SMART are crucial to accelerating progress in health research, generating robust evidence at pace and supporting faster translation of research into patient benefit.
This is particularly important in dementia and Alzheimer’s disease research, where there is an urgent clinical need for new therapeutic options.
This UK DRI-led trial draws on expertise across the MRC’s institutes, the MRC Centre of Research Excellence in Clinical Trial Innovation, and the Dementia Trials Accelerator, which speeds up recruitment into clinical trials, to evaluate promising interventions more rapidly, and hopefully bring new treatment options to the people who need them.
Improving quality of life
Science Minister, Chris McDonald MP said:
Dementia has a devastating impact on millions of people, both for those living with the illness and for their friends and families.
There is still so much we need to learn about how this disease works so we can then find the best ways to treat it, but this programme can help us bridge the gap.
AD-SMART will help to uncover potential new treatments faster by exploring how existing drugs might be used to treat dementia, giving hope that we might be able to find ways to improve patients’ quality of life in the future.
Further information
People with a confirmed Alzheimer’s diagnosis who would like to take part can register their interest by:
- contacting the AD-SMART recruitment co-ordinator at adsmart@psych.ox.ac.uk or on 01865 283806
- contacting the Alzheimer’s Research UK Infoline at infoline@alzheimersresearchuk.org or on 0300 111 5111
To take part in this study and find other opportunities to participate in ground breaking trials, visit Join Dementia Research.