A drug could reduce early Alzheimer’s by up to 60 percent in a breakthrough known as a ‘turning point’ in the fight against the disease.
In a ‘defining moment’ for dementia research, trial results of donanemab showed that it significantly delayed the deterioration of symptoms in people with this form of dementia.
It is the second treatment after lecanemab to offer hope to patients in what experts hail as the ‘decade of Alzheimer’s’, which could one day rival other long-term conditions such as asthma or diabetes.
Scientists say it ends a decades-long debate over whether sticky plaques or the accumulation of amyloid are at least partially responsible for the degenerative disease.
Donanemeb is given to Alzheimer’s patients by IV infusion once a month. Monoclonal antibodies—a man-made version of proteins produced by the body to fight harmful substances—travel to the brain. Once inside the organ, donanemab binds to the toxic build-up of amyloid plaques—a hallmark of the memory-robbing disease. This prompts immune cells known as microglia to clear
Researchers today unveiled that donanemab reduced Alzheimer’s cognitive decline by 35 percent 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 the company said it had already sought approval from US regulators, the Food and Drug Administration (FDA).
The US pharmaceutical giant said it expects to file an appeal with UK regulators within 6 months. This means patients can start treatment with the drug within 18 months.
Dr Richard Oakley, associate director of research and innovation at the Alzheimer’s Society, said: ‘This really is a turning point in the fight against Alzheimer’s and the science is showing that it is possible to slow the disease.
‘Treatments like donanemab are the first step towards a future where Alzheimer’s disease can be treated as a long-term condition alongside diabetes or asthma – people can live with it, but they can have treatments that can effectively manage their symptoms and keep them going. To live life to the fullest.’
Given as a monthly infusion in the hospital, donanemab has been shown to halt mental decline for more than a year in about half of patients. It was most effective in people younger than 75 in the early stages of the disease, the new findings show.
Researchers compared nearly 1,800 people with early-stage Alzheimer’s with patients given donanemab or a dummy drug for 18 months.
Those in the very early stages of the disease, known as mild cognitive impairment, benefited the most, with a 60 percent reduction compared to placebo.
In early Alzheimer’s patients whose brain scans showed low or moderate levels of a protein called tau, the drug was shown to slow clinical decline by 35 percent.
Levels of tau are a marker of how far the disease has progressed. When the results were combined to include those with higher levels of that protein, there was a 22 percent slower progression of the disease.
The researchers said some patients were taken off the drug after less than six months because scans showed the amyloid in their brains had completely disappeared.
Comparing it to radiation treatment for cancer, they said the treatment could then be stopped – with early indications that plaques that had built up over decades, would take years to return.
The drug works by using the immune system to remove amyloid – the toxic plaque that forms in the brain that stops brain cells from communicating.
As a result, it is only effective in 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 advance for the disease, which until just a few months ago had no specific treatment.
This comes after Eisai and Biogen’s lecanemab showed a 27 percent slower reduction, leading to its FDA approval earlier this month.
Scientists say the success of both donanemeb and lecanemeb ends a decades-long debate over whether amyloid—the accumulation of sticky plaques—is at least partially responsible for the degenerative disease.
Dr Maria Carrillo of the Alzheimer’s Association said: ‘With this fuller picture, there is additional, convincing scientific evidence that thorough removal of beta amyloid from the brain is associated with a significant slowing of disease progression in people with early Alzheimer’s.
The results show that starting treatment as early as possible enables the possibility of a greater beneficial effect, but also that starting treatment after disease progression is likely to slow disease progression.
‘These benefits are tangible 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 by an average of 4.5 to 7.5 months, the drug meant patients could continue with daily activities for longer, the researchers said.
Dr. Mark Mintun, Lilly’s group vice-president of neuroscience research and development and president of Avid Radiopharmaceuticals, says it’s early, symptomatic Alzheimer’s to ‘keep working, enjoy traveling, share quality time with family’ and ‘feel like yourself’. Can help with disease. For many days’.
However, the treatment was not without some serious side effects such as brain swelling, which occurred in a third of patients in the donanemab trial.
In most cases, the problem resolves without causing symptoms. But there were three deaths associated with taking the drug, at least two of which were thought to be due to swelling or bleeding.
Experts say patients need to be aware of the risks of treatment so they can choose whether to take these drugs.
Professor Paresh Malhotra, head of neurology at Imperial College London, said: ‘If the drug is approved in the UK, NHS services will need to adapt enough to deliver it and honest discussions between patients, carers and doctors will be needed. about the benefits and risks associated with such treatment.’
The UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), will now determine whether both drugs are safe for use in the UK before medicines watchdog NICE assesses whether they are cost-effective for the NHS.
These processes could take at least 18 months, giving the health service time to prepare for any mass roll-out.
Dr Susan Kohlhaus of Alzheimer’s Research UK said today’s announcement marked ‘another milestone’ after decades of research.
He said: ‘We are entering a new era where Alzheimer’s disease may be curable.
‘As a potential first-generation treatment, the effects of donanemeb are modest. But these results also confirm that removing amyloid from the brain can change the course of Alzheimer’s and help people with this devastating disease if treated at the right time.
‘Set against this, it is clear that donanemeb comes with side effects, which can be very serious for some. Regulators need to balance these benefits and risks before granting a license for its use.’
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