A new drug called donanimab has been hailed as a turning point in the fight against Alzheimer’s disease, after results from a global trial confirmed that it slows cognitive decline.
Antibody medication helps in the early stages of the disease by getting rid of a protein that builds up in the brains of people with this type of dementia.
Although not a cure-all, charities say the findings, published in JAMA The Journal of the American Medical Association, mark a new era in which Alzheimer’s disease can be treated.
The UK’s Medicines Regulatory Authority has begun evaluating it for possible 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 about a third, allowing people to maintain a greater portion of their daily lives and tasks, such as preparing meals and enjoying hobbies.
Mike Cooley, 80, one of dozens of patients in the UK who took part in the global trial, he and his family spoke exclusively to the BBC.
Mike receives an injection of the drug every month at a clinic in London and says he is “one of the luckiest people in the world”.
Mike and his family noticed that he had problems with memory and decision-making shortly before he began participating in the experiment.
His son, Mark, said it was very difficult to see his father struggle at first: “It was very difficult to see him struggle with information processing and problem solving, but I think the regression is on the way to stabilization.”
He added, “I feel more confident every day.”
The drug donanimab, which is being produced by Eli Lilly, works in the same way as lekanimab – developed by Izae and Biogen – which 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 up to a third of the patients in the dunanimab trial, and for most of them, it resolved without symptoms. However, two volunteers, and possibly a third, died as a result of serious enlargement of the brain.
Another Alzheimer’s drug called aducanumab was recently rejected by European regulators, due to safety concerns and a lack of sufficient evidence of its effectiveness for patients.
What is dementia and what can be done about it?
In the dunanimab trial, researchers studied 1,736 people ages 60 to 85 with early-stage Alzheimer’s disease.
Half of them received a monthly injection of the treatment and the other half received a placebo, also known as a dummy drink, over the course of 18 months.
- The drug appears to have a moral benefit, at least for some patients.
- Those with early-stage disease who initially had less amyloid in the brain benefited more, in terms of clearing up seen on brain scans.
- People who received the drug were also able to retain more of their daily lives, such as discussing current events, answering the phone, and pursuing hobbies.
- The disease slowed down, depending on what people were doing in their daily lives, by 20-30% overall, and by 30-40% in the group of patients the researchers thought were more likely to respond.
- There have been notable side effects and patients should be made aware of the risks of treatment.
- Half of the patients who received dunanimab were able to stop treatment after a year, because it had sufficiently cleared brain deposits.
Amyloid is only one part of the complex picture of Alzheimer’s disease, and it’s not clear whether treatment will continue to make a greater difference in the long term, experts warn.
The drug’s effects may be modest, but the results provide further confirmation that removing amyloid from the brain may alter the course of Alzheimer’s disease, and help people affected by this serious disease if treated in time, they say.
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 Alzheimer’s treatments, so it’s really encouraging to see continued tangible 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 beginning to change, and we are entering a new era where Alzheimer’s disease can become treatable. “
Speaking to BBC Radio 4’s BM programme, former prime minister David Cameron said resources should be directed to further research into what he called “statins for the brain”.
He said: “We would like a pill that people with a buildup of these proteins in the brain can take daily or weekly in order to get rid of those proteins in the brain and thus reduce your chances of developing a disease that causes dementia.”
Asked if the government was willing to invest where needed to roll out new therapies, Mr Cameron said there was a real incentive to do so: “We are a country of sixty million people and one million people with dementia, many of whom are in very expensive residential care settings, so there is a lot of The savings that can be made from treating people effectively…. I’m optimistic our system can achieve that.”
Licanimab costs about $27,500 in the United States, where it is licensed.
It is not clear how much donanimab will cost and how long it may take to get approval in the UK, but Alzheimer’s experts said having two drugs helps promote price competition.
The UK’s Medicines Regulatory Authority announced that it had already started work on evaluating dunanimab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease.
A spokesperson for the Medicines Regulatory Authority said: “Our aim is to make recommendations on its use in the (NHS) as soon as possible after it receives a UK licence.”
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 that 12 months ago,” he told the BBC.
His son, Mark, added: “I didn’t expect to see my dad so lively again, it’s an incredible moment.”
Dr Emer McSweeney, a consultant in neurodiagnostic radiology, who led the trials of donanimab in the UK, said: “This is extremely important and one of the major breakthroughs.”
The Alzheimer’s Society said: “This is truly a turning point in the fight against the disease, and the science is proving it is possible to slow the disease.”
Around 720,000 people in the UK could benefit from these emerging new therapies for disease if they are approved for use, but the Alzheimer’s Society has said the NHS is simply not fully prepared to offer them.
Kate Lee, chief executive of the charity, said: “A proper and prompt diagnosis is key, and currently only 2% of people in England and Wales receive their diagnosis through the specialist tests needed to be eligible for these therapies.”
“In addition, these emerging Alzheimer’s drugs require regular injections and follow-up, and the National Health Service’s preparations to implement this on a large scale have not yet been completed.”