‘Turning point in the fight against Alzheimer’s’ as drug found to slow disease
A new Alzheimer's drug could help bring about "the beginning of the end" for the disease. Health and Science correspondent Martin Stew has the latest
A new drug has been hailed as a “turning point in the fight against Alzheimer’s” after it was found to slow the progression of the disease.
Donanemab was found to slow “clinical decline” by up to 35%, meaning that people with disease could still go about performing day-to-day tasks including shopping, housekeeping, managing finances and taking medication.
Alzheimer’s Research UK said that “we’re entering a new era where Alzheimer’s disease could become treatable”.
And the Alzheimer’s Society said treatments like donanemab could one day mean Alzheimer’s could be likened to other long-term conditions such as asthma or diabetes.
The charity said new treatments including donanemab – which works by removing a protein called amyloid that builds up in the brains of people with Alzheimer’s – heralds a “new era” for Alzheimer’s disease.
CEO and Medical Director of Re:Cognition Health, Dr Emer MacSweeney explains how donanemab differs from other Alzheimer's treatments
It comes as scientists published the final results of the trial – known as TRAILBLAZER ALZ-2 – examining the safety and efficacy of the drug, manufactured by Eli Lilly and Company.
Researchers examined almost 1,800 people with early-stage Alzheimer’s.
Half of them received a monthly infusion of donanemab and the other half were given a dummy drug, also known as a placebo, over 18 months.
The study - published in the Journal of the American Medical Association and presented to the Alzheimer’s Association International Conference in Amsterdam - concluded that after 76 weeks of treatment, donanemab was able to slow clinical decline by 35.1% in people with early Alzheimer’s whose brain scans showed low or medium levels of a protein called tau.
When the results were combined for people who had different levels of this protein, there was a 22.3% slowing in disease progression.
The results come after another drug – lecanemab – was found to reduce memory decline among patients with early-stage disease.
How is donanemab taken?
Donanemab is an immunotherapy drug, similar to those used to treat different diseases such as cancers.
They tell the body’s immune system to attack foreign cells or proteins and get rid of them so they can’t cause any more problems.
Donanemab teaches the immune cells to recognise and remove a protein called amyloid, which builds up in Alzheimer’s disease.
The amyloid protein build-ups are thought to be toxic to brain cells, causing them to get sick and eventually die, leading to the symptoms of Alzheimer’s disease.
Donanemab is given to patients intravenously, which means into a vein through a drip bag.
Who will be eligible to use donanemab?
To be eligible for the new drug, patients would need to be in the early stages of Alzheimer's disease. This is due to the amount of amyloid protein buildup present in the brain.
Researchers believe these types of drugs may not be effective for people with moderate or severe Alzheimer’s disease, as the amyloid protein will have already caused too much damage to the brain for the drug to help.
Amyloid proteins can be detected by using PET scans or testing of spinal fluid - something that could prevent the drug from being readily available on the NHS due to a lack of scanners.
ITV News Health Correspondent Martin Stew said: "It works much better the earlier a diagnosis happens. We don't have very many scanners in this country, so at this moment in time, only 2% of the population are going to be diagnosed early enough for this to have a real impact."
Head of policy at Alzheimer's Research UK, David Thomas said: "There is a real risk of a postcode lottery when it comes to early diagnosis. PET scanners are one way we try and secure a early diagnosis, but they are very expensive, highly in demand and not many places have one.
"Another way we can diagnose people with Alzheimer's Disease is through a spinal fluid test, but wouldn't normally have one if there isn't a particular reason. Early diagnosis is key to this being a viable treatment, and for that to happen, there needs to be change in how Dementia is treated as a whole.
"There are some challenges ahead, but this drug is a monumental moment and real turning point, it provides a platform towards the overall aim of finding a cure."
Are there any side effects?
During the trial, researchers found that among a small number of people in the study there were some serious side effects such as brain swelling.
Meanwhile three deaths in the donanemab group and one in the placebo group were considered “treatment related”.
Many of the adverse effects experienced by people taking donanemab were also due to reactions from the intravenous drip, which is not uncommon.
This will be carefully considered alongside the benefits of the drug by regulatory authorities.
They will decide whether the drug should be made available to people with early stage Alzheimer’s disease.
Speaking about the results, Dr Richard Oakley, associate director of research and innovation at Alzheimer’s Society, said: “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.
“Today’s full results support what we heard about donanemab back in May, that the drug is able to slow down the progression of Alzheimer’s disease by more than 20%.
“This study adds to the growing evidence that treating people as early as possible may be more beneficial, with the effects of donanemab greater in people who were at an earlier stage of the disease.
“Diagnosis will be key to the access of any new treatments.
“We can’t have a situation where treatments are approved for use in the UK but people aren’t diagnosed early or accurately enough to be eligible.
“We need early, and accurate, diagnoses available for everyone and the NHS ready to roll out treatments such as donanemab and lecanemab if and when they are approved in the UK.”
He 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.
“We should also note that the majority of people who took part in this trial were white – it’s crucial that in future trials we see more diversity to prove that new drug treatments have similar effects for everyone living with Alzheimer’s disease.
“Just as we’ve seen a transformation in cancer treatment in recent decades, we’re really hopeful we’re on the same path for dementia.”
When might donanemab be available in the UK?
To be available for use in the UK, a drug needs to be approved for use by the Medical and Healthcare Products Regulatory Agency (MHRA) But this only allows it to be legally used in the UK.
For it to be available on the NHS it will then also need to be reviewed by the National Institute of Health and Care Excellence (NICE).
They will consider the cost-effectiveness of donanemab, as well as the benefits and side effects.
Something that Alzheimer's Research UK are particularly worried about is the costing of the drug. While a price is yet to be set for donanemab, it is unlikely to be cheap.
David Thomas, head of policy at the charity said: "A lot of dementia treatment costs are taken on by unpaid carers. This drug could help not just dementia patients, but caregiver outcomes as well. There are worries that the costs taken on by unpaid caregivers won't be considered by NICE."
According to Alzheimer's Society, if decisions are positive, the very earliest donanemab might be available on the NHS is 2025.
Dr Susan Kohlhaas, executive director of research and partnerships at Alzheimer’s Research UK, said: “Today’s announcement marks another milestone.
“Thanks to decades of research, the outlook for dementia and its impact on people and society is finally changing, and we’re entering a new era where Alzheimer’s disease could become treatable.
“As a potential first-generation treatment, donanemab’s effects are modest.
“But these results provide further confirmation that removing amyloid from the brain can change the course of Alzheimer’s, and may help people affected by this devastating disease if they’re treated at the right time.
“Set against this, it’s clear that donanemab does come with side effects, which for some can be very serious.
“Regulators will need to balance these benefits and risks before it is given a license for use.
“People living with Alzheimer’s deserve access to safe and effective treatments urgently.
“That’s why Alzheimer’s Research UK has written to the drug’s manufacturer, Eli Lilly, calling on them to put donanemab forward for regulatory review in the UK without delay.
“And this review should be conducted by the UK regulators as a priority.”
Sir John Hardy, professor of neuroscience and group leader at the UK Dementia Research Institute, UCL, added: “Scientists now need to work to understand what we need to do to stop the disease rather than just slow it, but the major immediate task will be to organise NHS Alzheimer provision to be able to use these therapies.”
Want a quick and expert briefing on the biggest news stories? Listen to our latest podcasts to find out What You Need To Know.