‘A turning point’ for the treatment of Alzheimer’s – the new drugs that could change lives

Dr Richard Oakley, Associate Director of Research and Innovation at Alzheimer’s Society, said that after 20 years with no new drugs for the disease, this is exciting news. 

He says: “This is truly a turning point in the fight against Alzheimer’s and science is proving that it is possible to slow down the disease.  

“Treatments like donanemab are the first steps towards a future where Alzheimer’s disease could be considered a long-term condition alongside diabetes or asthma. People may have to live with it, but they could have treatments that allow them to effectively manage their symptoms and continue to live fulfilled lives.” 

Donanemab is a monoclonal antibody – a man-made protein that acts like an antibody. It works by clearing plaque clusters from the brain known as amyloid, which are closely associated with Alzheimer’s disease. It is taken as a once-a-month injection for up to 18 months, or until the clusters have been cleared. 

The trial involved 1,736 people aged 60 to 85 (half of whom received the drug, whilst the other half had a placebo or “dummy” injection). Researchers found the drug slowed the “clinical decline” by up to 35%, allowing people with Alzheimer’s to continue performing day-to-day tasks such as shopping, pursuing hobbies, housekeeping, managing their finances and taking medication. 

Because it targets the clusters, donanemab only works in Alzheimer’s disease, not in other types of dementia, such as vascular dementia. 

Donanemab is manufactured by Eli Lilly. The drugs company unveiled the full results of its clinical trials at the Alzheimer’s Association International Conference in Amsterdam on Monday. 

It is the second new drug announced in less than a year. Lecanemab works in the same way as donanemab and was found to slow the rate of cognitive decline in Alzheimer’s by 27 per cent. It was approved for use in the US on July 6th, and is currently being considered for approval in the UK. 

Although this is a breakthrough, experts say it isn’t a miracle cure. 

Professor Paresh Malhotra, head of neurology at Imperial College London, said: “It is important to stress that donanemab does not improve symptoms but slows down deterioration. It should also be noted that the drug seems to be more effective at earlier stages of disease. And although the effect of the drug will be described as being about a third, it consists, on average, of a difference of about three points on a 144-point combined scale of thinking and daily activities.  

“If the drug is approved in the UK, then NHS services will need to adapt considerably to provide it and there will need to be honest discussion between patients, carers, and doctors about the benefits and risks associated with this type of treatment. But overall, having drugs that slow progression is a very, very significant step.”  

Professor Gill Livingston, Professor of Psychiatry of Older People at University College London, said: “We do not know if the treatment will continue to make more difference over a longer period. This is the hope but not what we know. Thus, it is a beginning and important but with a small change in a relatively physically well population and significant side effects, there is still a lot of work to do to know what it means for most people with Alzheimer’s dementia.  We also do not know its cost and therefore whether it will reach UK value thresholds.” 

Oakley added: “It’s also important to note that side effects did occur, although serious side effects only occurred in 1.6% of people receiving the drug. Regulators will need to balance these side effects against the benefits of the drug.”  

The clinical trials didn’t differentiate between men and women and most of those in the trial were white, so we don’t know whether the drug works equally well in men and women, or in people from different ethnic backgrounds. 

Prof Nick Fox, Professor of Neurology and Group Leader at the UK Dementia Research Institute at University College London (UCL), says donanemab has the best effect on those in the early stages of Alzheimer’s. 

He says: “Those who were less affected at baseline derived greater benefit, with 30-40% slowing across a range of clinical measures – but the whole (combined) group still saw 20-30% slowing on these measures, which is very encouraging. 

“The challenge will be to deliver these therapies in already stretched health care systems and to do so safely.” 

Doctors are already proposing changes to help with diagnosis with a new seven-point rating scale. The revamp is designed to help doctors deal with new diagnostic tests and these new drugs. 

Donanemab could be licensed as safe in the UK in as little as a year to 18 months, although that’s not the same thing as the NHS funding it.  

Oakley says: “Realistically 2025 is the earliest this drug might be made available via the NHS.  

“A drug will not become available in the UK or Europe without having strong evidence to show that it is both safe and effective as a treatment.”  

Although the cost is yet to be revealed, researchers have suggested it could be priced at $1,600 (£1,273) per dose, or $20,000 (£15,909) annually. 

The drug can only be given to people who’ve had a specialist brain scan called a PET (positron emission tomography) scan, to look at the amyloid plaques, meaning that these high-tech scans would need to be more widely available. 

Previous reports investigating the readiness of the NHS to adapt systems to allow for people to take lecanemab found that service simply wasn’t set up to accommodate the testing, support and analysis needed to deliver the new Alzheimer’s drug – and a similar situation would likely be found for donanemab.

The NHS will have to weigh up the cost-effectiveness to decide who should receive the drug and there are fears it may only be available to those who can afford to go private. 

Hilary Evans, chief executive of Alzheimer’s Research UK, told Sky News: “The worst-case scenario… is if it is only available in certain big university hospitals or for people who can maybe afford to pay privately. That is not what we want to see.  

“We want to make sure that the NHS is prepared as these treatments start coming through – we need to ensure that those conversations start now.” 

Secretary of State for Health and Social Care, Steve Barclay, said: “To protect patients all medicines have to go through the MHRA and NICE’s regulatory processes, but NHS England has in place a dedicated team to ensure the quickest possible rollout for if and when Donanemab is approved.”