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A drug can slow early Alzheimer’s by up to 60 per cent in a breakthrough hailed as the ‘turning point’ in the fight against the disease.
In a ‘defining moment’ for dementia research, results from trials of donanemab found it significantly delayed the worsening of symptoms in people with this type of dementia.
Scientists said it also ended the decades-long debate over whether the accumulation of sticky plaques, or amyloid, is at least partly responsible for the degenerative disease.
Donanemab is given to Alzheimer’s patients through an IV infusion once a month. The monoclonal antibody — a man-made version of proteins produced by the body to fight-off harmful substances — travels to the brain . Once inside the organ, donanemab binds to toxic build-ups of amyloid plaque — a hallmark sign of the memory-robbing disease. This prompts immune cells, known as microglia, to clear them
Researchers today unveiled that donanemab slowed cognitive decline in Alzheimer’s by 35 per cent by removing toxic plaques in the brain
Unveiling the full trial results at the Alzheimer’s Association International Conference in Amsterdam yesterday, Eli Lilly and Company said it had already sought approval from US regulators the Food and Drug Administration (FDA).
The US pharmaceutical giant said it expected to apply to UK regulators within 6 months. It means patients could start being treated with the drug in as little as 18 months.
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.’
Given as a monthly infusion in hospital, donanemab was found to halt mental decline for more than a year in around half of patients. It was most effective in under-75s in the earliest stages of disease, the new results showed.
Researchers examined almost 1,800 people with early-stage Alzheimer’s with patients given either donanemab or a dummy drug over 18 months.
Those at the very earliest stage of disease, known as mild cognitive impairment, had the greatest benefit, with a 60 per cent slowing of decline compared to placebo.
Among patients with early Alzheimer’s whose brain scans showed low or medium levels of a protein called tau, the drug was found to slow clinical decline by 35 per cent.
Levels of tau are a marker of how far the disease has progressed. When the results were combined to include people who had higher levels of that protein, there was a 22 per cent slowing in disease progression.
Researchers said some patients were taken off the drugs after as little as six months because scans showed the amyloid in their brains had completely disappeared.
Likening it to radiation treatment for cancer, they said treatment could then stop – with early indications suggesting the plaques which were decades in the making, would take several years to return.
The drug works by using the immune system to remove amyloid – toxic plaque build-ups in the brain that stop brain cells communicating.
Consequently, it is only effective for people with early-stage Alzheimer’s and not other forms of the disease, such as vascular or frontotemporal dementia.
But the findings represent a major breakthrough for the disease, which until just months ago had no definitive treatments.
It comes after Eisai and Biogen’s lecanemab was shown to slow decline by 27 per cent, leading to its FDA approval earlier this month.
Scientists said the successes of both donanemab and lecanemab ended the decades-long debate over whether the accumulation of sticky plaques – amyloid- is at least partly responsible for the degenerative disease.
Dr Maria Carrillo, from the Alzheimer’s Association, said: ‘With this fuller picture, there is additional, convincing scientific evidence that thoroughly removing beta amyloid from the brain is associated with significant slowing of disease progression in people living with early Alzheimer’s.
‘The results illustrate that initiating treatment as early as possible enables the possibility of a bigger beneficial effect, but also that there is potential for slowing of disease progression even when treatment is started later in the disease progression.
‘These benefits are real and meaningful, giving people more time to participate in daily life, remain independent and make future health care decisions.’
As well as delaying the worsening of symptoms for between 4.5 to 7.5 months on average, the drug also meant patients could continue to perform daily activities for longer, researchers said.
Dr Mark Mintun, group vice-president of neuroscience research and development at Lilly and president of Avid Radiopharmaceuticals, said it could help early, symptomatic Alzheimer’s disease to ‘keep working, enjoying trips, sharing quality time with family’ and ‘feel like themselves, for longer’.
However, the treatment was not without some serious side effects such as brain swelling, which occurred in up to a third of patients in the donanemab trial.
For most, the issue resolved without causing symptoms. But there were three deaths that were linked to taking the medication, with at least two thought to be the result of swelling or bleeds.
Experts said patients will need to be aware of risks of treatment so they can choose whether they take these drugs.
Professor Paresh Malhotra, head of neurology at Imperial College London, said: ‘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.’
The UK’s regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), will now determine if both drugs are safe for UK use before drug’s watchdog NICE assesses whether they are cost effective for the NHS.
These processes are likely to take at least 18 months, giving the health service time to gear up for any mass roll-out.
Dr Susan Kohlhaas, of Alzheimer’s Research UK, said today’s announcement ‘marks another milestone’ following decades of research.
She said: ‘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.’
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