The trial is starting with two existing treatments that could be repurposed (Image: Getty)
A pioneering dementia study is set to halve the time required to test promising Alzheimer’s treatments by evaluating multiple drugs simultaneously. Researchers have begun recruiting 1,200 people to test two existing medicines that could be repurposed.
Patients will be randomly assigned to receive either a placebo, an ADHD drug called atomoxetine or the diabetes drug metformin. If successful, the treatments could be rolled out for dementia much sooner than new medicines that have not previously been tested in humans.
Experts expect to add more drugs — both existing and new — to the study in the coming years. They likened the traditional approach of testing only one drug against a placebo to building a football stadium to play a single match.
Multi-arm trials have been successfully used for cancer, motor neurone disease, and to find Covid treatments during the pandemic.
Chief investigator Professor Paresh Malhotra, of Imperial College London, said a new approach was needed because “we just are not testing the most promising treatments for Alzheimer’s disease quickly enough, and we are not getting enough people with clinical Alzheimer’s disease into trials”.
Trial participants will be monitored while taking a drug or placebo (Image: Getty)
He added: “Last year, 2025-26, around 200 people were recruited into Alzheimer’s trials in the UK and in this trial alone we intend to recruit 1,200 people over the next four years.”
The AD-SMART(Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial) study is being led by the UK Dementia Research Institute (UKDRI) and Alzheimer’s Research UK.
Researchers said it would be the first multi-arm study to test drugs in a real-world population with dementia over a significant period of time.
And it will be open to a wider group of patients than many drug trials which target only those with mild cognitive impairment or in the earliest stages of Alzheimer’s.
Atomoxetine was chosen for the trial because it targets the chemical noradrenaline, which regulates attention, memory and stress responses in the brain. Regions of the brain responsible for producing noradrenaline are known to be affected by Alzheimer’s disease.
Early research has also suggested that diabetic people taking metformin have a lower risk of developing dementia, which may be linked to its effects on inflammation and insulin resistance.
Prof Malhotra said the two drugs selected were “undoubtedly cheaper” than treatments such as lecanemab and donanemab, which have been proven to slow progression of Alzheimer’s but rejected for NHS use on cost grounds.
He added: “We very much hope that they will provide an alternative or perhaps a combination with whatever comes after lecanemab and donanemab.” The first interim results are expected in around two and a half years, with full results due in late 2030.
The trial is backed by £4.2million from the Medical Research Council and NIHR. Prime Minister Andy Burnham, whose father Roy died with Alzheimer’s in September, 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.”
Professor Siddharthan Chandran, director of the UKDRI, said it was a “very exciting time”, with major advances in both diagnostics and treatments for Alzheimer’s. But he warned that for too long, treatments have been tested in a “grossly inefficient way”.
He added: “Because of the way SMART trials are designed, biotech and pharmaceutical companies can also bring their drugs straight into the trial.
“That means more treatments tested more quickly, and for people living with Alzheimer’s, that could make all the difference.”
Dr Sheona Scales, director of research at Alzheimer’s Research, UK said: “For people living with Alzheimer’s disease, time is precious.
“We urgently need more treatment options that can help people live better for longer and stay connected to the people they love.”
Heather, who has Alzheimer’s, and her partner Roger (Image: Heather Ransome)
Heather Ransome, 67, is among the first patients to join the AD-SMART study. She 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.”
Heather, who lives in the Isle of Wight with her partner Roger, said joining the trial had given her “some hope for the future”. She added: “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.”
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.
You can also contact the Alzheimer’s Research UK Infoline at infoline@alzheimersresearchuk.org or on 0300 111 5111.
