Susie ForrestBBC Scotland and
Morag KinniburghBBC Scotland
BBC
Roy Mitchell is one of just four people who have started an Alzheimer’s drug trial in Scotland
Although he struggles with his memory, Roy Mitchell knows he is glad to be among the first patients in the world to try a new medicine for Alzheimer’s disease.
The first four people have been enrolled in the early-stage drug trial through a research centre in Edinburgh, and others will be recruited from across the UK and Netherlands.
But experts say Scotland is lagging behind in new dementia research that could see many more patients like Roy offered experimental treatments.
They are calling on the Scottish and UK governments to do more to improve access to drug trials for Alzheimer’s disease, which is one of the leading causes of death in Scotland.
Three intravenous infusions
Roy, 69, who travels from his home in Perth to take part in the trial, has been given a series of three intravenous infusions, each four weeks apart.
He’ll be monitored with brain scans, blood tests and spinal fluid samples taken over a ten-month period after that.
It costs Roy nothing, and he says there is no pain during the infusions. Although he has “not got a clue” what the drug is doing, he wants to encourage others to get involved.
“It seems an immense responsibility in many ways to be doing it,” says Roy.
“People of my age have had our past, it’s the people coming behind.
“For the people coming after us, things will get better and better, we would hope, and if I have to make a wee sacrifice that’s fine.
“I would definitely recommend other people get on board.”
Kirsty Mitchell said they were sent away from the hospital with a leaflet and told Roy would die of the disease
Unlike recent drug discoveries which work on amyloid proteins that build up in the brain, this medication, known as THN391, targets fibrin, another protein involved in clotting and inflammation that can damage the brain’s blood vessels.
It is still at a very early stage of development, but Roy’s wife Kirsty says the trial has given them hope, where the NHS could not.
She says that when Roy was diagnosed in November 2022, they were sent out the door with a leaflet, and told that he would die of the disease.
“When we first got the diagnosis, I was sure we would be the ones to beat it. We’d be the ones that would be different. We’re not going to be that.
“My fear is that his decline is going to be very fast and I lose him much earlier than I want to. I’d prefer not to lose him at all.”
Participants in the trial have a three in four chance of receiving THN391, and a one in four chance of receiving a placebo.
“The fact that you are doing something, rather than sitting around allowing this illness to just happen, it gives you purpose, so it was a no-brainer,” says Kirsty.
“The first person to be cured of Alzheimer’s will be on a clinical trial, they’ll have to be. And so when the NHS can’t give us hope for a cure, this gives us hope.”
Getty Images
The trial participants will have brain scans, as well as blood tests and spinal fluid samples taken over a ten-month period
In 2023-24, around 1,000 patients in Scotland were recruited to drug trials for dementia and other neurodegenerative conditions, compared to more than 3,000 on cancer drug trials and over 4,000 on drugs for cardiovascular conditions.
Henry Simmons, chief executive of Alzheimer Scotland, says he would love to see everyone with dementia get the opportunity to participate in clinical trials.
But he says the infrastructure needed to support more research and treatment in this area is lagging behind other specialisms.
“I think the gaps that we’ve got when it comes to dementia practice are that the new treatments are very intensive in terms of what they require.
“If we’re going to be ready for some of the new treatments, we need to have access to scanners, we need to have access to IV infusions, we need to have access to treatment centres, and better diagnostic materials.
“When you think about cancer drugs and cancer treatments, you’ve got the Beatson, you’ve got an infrastructure, everywhere’s got a really big economy of scale to build on.
“When it comes to treatments for people with dementia, there’s none of that. And our worry is that when you’ve not had that investment, you’re starting from quite a long way back.”
Dr Meher Lad from Scottish Brain Sciences says this drug is at the very beginning of its research journey
Earlier this year, two new drugs that have been shown in global trials to slow early-stage Alzheimer’s disease, donanemab and lecanemab, were rejected by the Scottish Medicines Consortium (SMC), meaning patients cannot access them on the NHS here. The same outcome was reached in England and Wales.
The SMC decided they did not offer value for money, partly because of the cost of delivering them, which includes needing extra scans and appointments.
Henry Simmonds says that on its own the NHS in Scotland is never going to have enough money or the right approach.
“The difficulty is that dementia research funding comes as part of the NHS funding, and the NHS hasn’t been set up as an innovator.
“We’re way behind where the science and the innovation is, and we’d like to see a bit of thinking done about how we can move that forward and close that gap.
“So we need to work together with government to really sell Scotland as the place to come to invest in research.”
The UK government, which is investing hundreds of millions of pounds in dementia research, should give Scotland a fair share of that investment to help build more partnerships between private companies, universities and the NHS, according to Mr Simmonds.
The trial Roy is taking part in is being run by Scottish Brain Sciences, a private company that delivers clinical research into Alzheimer’s disease, funded by pharmaceutical companies, at no cost to patients.
Tipping point
Dr Meher Lad, their clinical lead, says THN391 is at the very beginning of the journey for a drug being approved for wider use.
“It’s an early study to find out whether the drug is safe and can be tolerated.
“After this, bigger, broader studies around the world will test whether it works and alters people’s memory and thinking for the better.
“It gives me hope that it opens the door for newer therapies that might be more appropriate for the NHS in Scotland and beyond.”
Dr Lad says it is just one of many recent exciting developments in dementia research, and the challenge now is to think about how to deliver the benefits to many more patients.
“There’s been a lot of development in terms of blood tests that can detect Alzheimer’s disease at an early stage, and now it’s time to move that into the clinic so we can help people who are suffering from memory and thinking problems.
“And I think we are perhaps at the tipping point where we can make this happen.”
A spokesperson for the Scottish government said it was working to deliver a ten-year dementia strategy and provides £46m annually to fund “vital” clinical trials for such diseases.
The UK government said it was also investing in clinical trials and backing ground-breaking research to help diagnose, as well as support, people living with dementia.
