BBCA clinical trial has been launched in the UK which scientists hope could cut years from the search for new treatments for Alzheimer’s disease.
It will test multiple drugs simultaneously, starting with two repurposed medicines already used to treat type 2 diabetes and attention deficit hyperactivity disorder (ADHD).
The study will examine whether the drugs can lessen symptoms such as memory and thinking problems, and help people maintain their quality of life.
Angela Bucksey, 67, from Cambridgeshire, was diagnosed with Alzheimer’s in January and is the first person to begin treatment on the trial, called AD-SMART.
“My mother had it and my aunts, so it was a disappointment rather than a shock when I was diagnosed because I knew it would restrict my life.
“But I was determined that it wasn’t going to define me.”
Angela said she felt empowered joining the trial because “at least you are doing something”.
“Instead of just sitting there, you’re standing up and saying, I will fight back.”
Alzheimer’s is the most common type of dementia, affecting around 600,000 people in the UK.
‘Cutting-edge treatments’
Prime Minister Andy Burnham, whose father died from Alzheimer’s last month, said he knew how it felt to lose a loved one to dementia, and had seen first-hand the devastating impact of the disease 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,” he said.
The AD-SMART study is what’s known as a multi-arm, multi-stage platform trial where several treatments are tested simultaneously, with the results compared with one group of participants taking a placebo or dummy.
This means those involved have a higher likelihood of getting an active treatment than in a traditional trial.
If any drug isn’t showing benefit it can be dropped quickly and a new treatment added in its place – the approach has been used successfully in cancer and motor neurone disease.
The two initial drugs being tested are metformin, used to treat type 2 diabetes, and atomoxetine, for ADHD, which were selected by an international panel of experts.
Both drugs may help reduce brain inflammation, which is a driver of neurodegeneration, said chief investigator Prof Paresh Malhotra, group leader at the UK Dementia Research Institute Centre for Care Research & Technology at Imperial College London.
“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,” he told the BBC.
“We are applying advances from cancer and other conditions to accelerate testing of treatments for people with Alzheimer’s disease.”
‘Back from despair’
For the drugs to be successful, the study has to show that they have beneficial effects on thinking and the ability to carry out everyday activities.
“That’s what patients and their carers care about,” said Prof Malhotra.
Some 1,200 participants with mild to moderate Alzheimer’s will be recruited at more than 30 sites across the UK. Sites in Cambridgeshire, Surrey, London, Southampton and Edinburgh are already open.
Scientists expect to finish evaluating the first drugs in 2030 and, in that time, additional treatments are likely to be added.
All the participants will have regular health checks including cognitive tests, which will help researchers assess how effective the treatments are.
Angela Bucksey’s husband Steve, who is her study partner, told the BBC: “Joining the trial has brought us back from the despair of a diagnosis which everybody recognises is non-recoverable.
“People who know we are on a drug trial understand that we’re doing something about it and, rather than be sorry for us, they can be encouraging.”
Dr Sheona Scales, director of research at Alzheimer’s Research UK said “time is precious” for people living with Alzheimer’s disease and more treatment options are urgently needed.
People with a confirmed Alzheimer’s diagnosis who would like to take part can register their interest on the AD-SMART website.
The trial is being led by the UK Dementia Research Institute and Alzheimer’s Research UK.
Partners include the National Institute for Health and Care Research, the Medical Research Council and Health Data Research UK, with funding by UK government.
