- author, Fergus Walsh and Michael Roberts
- stock, BBC News
A new drug called donanimab has been hailed as a breakthrough in the fight against Alzheimer’s disease, with results from a global trial confirming that it slows cognitive decline.
The antibody drug helps people with this type of dementia in the early stages of the disease by removing the protein that builds up in the brain.
Although there is no cure for everything, the charities say the findings, published in JAMA The Journal of the American Medical Association, mark a new era in the treatment of Alzheimer’s disease.
England’s Medicines Regulatory Authority has begun evaluating it for potential use in the National Health Service (NHS).
The drug works in Alzheimer’s disease but not in other types of dementia, such as vascular dementia.
In trials, it appears to slow the progression of the disease by a third, allowing people to maintain most of their daily living and tasks such as preparing meals and enjoying entertainment.
Mike Cooley, 80, was one of dozens of patients in the UK who took part in the global trial, and his family spoke exclusively to the BBC.
Mike receives injections of the drug every month at a clinic in London and says he is “one of the luckiest people in the world”.
Mike Cooley (left) with his son Mark
Mike and his family noticed that he was having trouble with memory and decision-making shortly before he began participating in the experiment.
His son Mark said watching his father struggle was tough at first: “Watching him struggle with information processing and problem solving was tough, but I think the regression is on the way to stabilization.”
He added, “I feel more confident every day.”
Eli Lilly’s drug tonanimab, which works similarly to leganimab – developed by Ise and Biogen – made headlines around the world when it was shown to slow the progression of the disease.
Although these drugs are very promising, they are not risk-free treatments.
Brain enlargement was a common side effect in one-third of patients in the dunamib trial, and most of them resolved asymptomatically. However, two volunteers and one-third died as a result of severe enlargement. the brain.
Another Alzheimer’s drug, aducanumab, was recently rejected by European regulators because of safety concerns and insufficient evidence of its effectiveness in patients.
What is dementia and what can be done about it?
In the dunanimab trial, researchers studied 1,736 people aged 60 to 85 with early-stage Alzheimer’s disease.
Half of them received a monthly injection of the treatment, while the other half received a placebo, also known as a dummy drink, over an 18-month period.
- The drug appears to have a moral advantage, at least for some patients.
- People with early-stage disease who initially had less amyloid in the brain benefited more, based on clarity seen on brain scans.
- Those who received the drug were able to maintain their daily lives, such as discussing current events, answering the phone, and pursuing hobbies.
- Depending on what people do in their daily lives, the disease declines as the researchers estimate that 20-30% overall and 30-40% of patient groups are more likely to respond.
- Significant side effects have occurred and patients should be made aware of the risks of treatment.
- About half of the patients who received dunanimab were able to stop treatment after one year because it sufficiently cleared brain deposits.
Amyloid is only one part of the complex picture of Alzheimer’s disease, and it’s unclear whether treatment will continue to make a big difference over the long term, experts caution.
The drug’s effects may be modest, but the results further confirm that removing amyloid from the brain can reverse the course of Alzheimer’s disease and help people with this serious disease if treated in time.
Professor Giles Hardingham, from Dementia Research UK, said: “It’s great to see these findings published in full today. We’ve waited a long time for a cure for Alzheimer’s, so it’s really encouraging to see continued solid progress in this area.”
Dr Susan Koolhaas from Alzheimer’s Research UK said: “Today’s announcement marks another milestone. Thanks to decades of research, expectations about dementia and its impact on people and society are finally starting to change, and we are entering a new era of Alzheimer’s disease being treatable.”
Speaking on BBC Radio 4’s BM programme, former Prime Minister David Cameron said evidence should be turned on to further research into what he called “statins for the brain”.
He said: “We want a pill that can be taken daily or weekly by people with excess of these proteins in the brain to clear the proteins in the brain, thereby reducing the chances of developing the disease that causes dementia.”
Asked if the government was prepared to invest where necessary to roll out new treatments, Mr Cameron said there was a real incentive to do so: “We are a country of sixty million people and a million people with dementia, many of whom have very expensive residential care systems, so we cannot treat people effectively. A lot of savings can be made through… I am confident that our system can achieve that.”
Licensed Licanimab costs about $27,500 in the United States.
It is unclear how much tonanimab will cost and how long it might take to gain approval in the UK, but Alzheimer’s experts said having two drugs could help promote price competition.
The UK’s Medicines Regulatory Authority has announced that it has already started work evaluating dunanimab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease.
A spokesman for the Medicines Regulatory Commission said: “Our aim is to make recommendations on its use (for the NHS) as soon as possible after receiving the UK licence.”
Mike is celebrating his 80th birthday
Mike Cooley celebrated his 80th birthday in April. At his birthday party, he surprised his family by performing “My Way” in front of 40 guests.
“That’s the confidence I have now, I wouldn’t have done it 12 months ago,” he told the BBC.
His son Mark added: “I never expected to see my dad so lively again, it was an incredible moment.”
Dr Emer McSweeney, a consultant in neurodiagnostic radiology who led the trials of tonanimab in the UK, said: “This is very important and one of the major breakthroughs.”
The Alzheimer’s Association said: “This is truly a breakthrough in the fight against the disease, and science is proving that it is possible to slow the disease.”
Around 720,000 people in the UK could benefit from these new treatments for the disease if they were approved for use, but the Alzheimer’s Association said the NHS was not fully prepared to provide them.
Kate Lee, chief executive of the charity, said: “Correct and prompt diagnosis is vital, as only 2% of people in England and Wales currently receive their diagnosis through the specialist tests needed to qualify for these treatments.”
“Furthermore, these emerging Alzheimer’s drugs require regular injections and follow-up, and the National Health Service’s preparations for implementing them on a large scale are not yet complete.”
“Award-winning beer geek. Extreme coffeeaholic. Introvert. Avid travel specialist. Hipster-friendly communicator.”
