- Donamab may block the progression of Alzheimer’s in a third stage, Eli Lilly said.
- Critics say the figures are ‘a bit skewed’ and drug effects may not be seen.
A ‘game-changing’ new Alzheimer’s drug could significantly slow down mental decline, scientists warned today.
Donamab can inhibit the development of memory-stealing disease by up to 60 percent, US pharmaceutical giant Eli Lilly said yesterday when it released final trial results.
But the figures on its effectiveness are based on the results of Alzheimer’s Assessment patient tests taken at the beginning and end of the 18-month study.
Critics say it is ‘a bit of a blur’ and the effects of the drugs may not even be visible to patients or their families.
However, other scientists have called on UK regulators to make swifter decisions to ensure Alzheimer’s patients ‘benefit from these treatments’.
Researchers studied nearly 1,800 people with early stage Alzheimer’s disease. Patients were on donumab or dummy treatment for more than 18 months.
Among patients with early Alzheimer’s disease whose brain scans showed low or moderate levels of the protein tau, the drug was found to reduce clinical decline by 35 percent.
This figure is based on the Integrated Alzheimer’s Disease Rating Scale (iADRS), which measures their cognition and function.
Patients’ ability to perform various activities such as writing, cooking, and shopping is rated on a scale of 0 to 144.
At the start of the 18-month trial, patients given a placebo pill scored an average of 105.5 out of 144. At the end of the study, they scored 96.23 – which means that their score increased by 9.27 points.
Meanwhile, those receiving monthly IV infusions of donamab were 105.7 at the start of the study and 99.5 at the end – a drop of 6.02 points.
This meant a difference of only 3.25 points between the groups, say critics.
Eli Lilly found that this meant that people who received their Alzheimer’s medication had a 35 percent slower progression of their disease.
However, critics say that the difference in scores is so small that most patients will not see a difference in Alzheimer’s symptoms.
Professor Alberto Espai, a neurologist at the University of Cincinnati in Ohio, told MailOnline: ‘On a scale of 144, [a 3.25 point difference] It’s not important. The minimum significance level for this scale is 5.
“Patients can’t tell the difference.”
Dr Matthew Schrag, a neurologist at Vanderbilt University, told MailOnline that it was a ‘minor miracle’ that Donamab could slow the progression of Alzheimer’s by a third.
He said: ‘The difference between the treatment and placebo groups was around 3 points.
“That’s the difference a patient or their family can experience and it’s a very small result – after 18 months of intensive and expensive treatments, most don’t realize it.’
“We have to be careful with this new class of drugs,” Dr. Schrag added. I think it is a mistake to release these treatments too quickly.
“These drugs have serious side effects, are difficult to administer and I am afraid that they are overly optimistic about the results related to memory.
The fight to find effective treatments is not over – Alzheimer’s patients need better treatments.’
Professor Robert Howard, an expert in geriatric mental health at University College London, said: “The 30 percent plus slow claim is not what the data really shows and it is worrying to look at the actual dose-placebo differences.
‘Regardless of the importance of holding out hope and preparing for better treatments, can we be realistic?’
however, Dr Richard Oakley, associate director of research and innovation at the Alzheimer’s Society, said the donamab results marked a ‘tipping point’ in the fight against Alzheimer’s.
Treatments like donamab are the first steps in a future where Alzheimer’s disease can be treated as a long-term condition with diabetes or asthma – people can live with the disease but have treatments that allow them to manage their lives more effectively. Signs and keep living a full life.’
Eli Lilly’s results also showed significant benefit in participants with mild cognitive impairment in the early stages of the disease, with a 60 percent reduction compared to placebo.
According to findings published in the Journal of the American Medical Association, when the results were combined for people with different levels of tau, there was a 22.3 percent reduction in disease progression.
Similar results, which have been widely anticipated in the dementia field for months, were presented at the same time at the Alzheimer’s Association International Conference in Amsterdam.
Donumab is given once a month by IV injection to Alzheimer’s patients
Monoclonal antibodies – a synthetic version of a protein produced by the body to fight harmful substances – then go to the brain.
Once inside the body, donamab binds to toxic amyloid plaques—a hallmark of memory-robbing disease. This stimulates immune cells known as microglia to clean up.
However, like any medical treatment, the drug is not without risks.
Serious side effects such as brain swelling and bleeding have been reported in some patients, as well as three drug-related deaths.
Eli Lilly wants to apply for a license to sell the drug in the UK in the next six months.
Experts hope this means it will be available on the NHS as soon as 2025.
Dr Susan Koolhaas, Director of Research and Partnerships at Alzheimer’s Research UK He told him Guardian: We need to see swift regulatory decisions so that people who could benefit from these treatments are not put under stress.
After 20 years without new Alzheimer’s drugs, people affected by the disease deserve answers about new treatments as soon as possible.
About 850,000 Britons and 5.8 million Americans have Alzheimer’s disease.
The disease is the main cause of dementia, in which patients have impaired memory, thinking and decision-making abilities that interfere with daily activities.
Dementia affects 900,000 people in the UK and approximately 7 million people in the US.
Because people are living longer, the disease is considered a global health threat. He It will increase the burden on health care systems, including in the UK.
Treating and caring for patients with Alzheimer’s disease and dementia is estimated to cost Britain £25 billion each year, according to Alzheimer’s Research UK, most of which is spent on social care.
MailOnline has contacted Eli Lilly for comment.
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