A breakthrough drug for Alzheimer’s disease may be introduced next year

Experts claimed today that Britons with Alzheimer’s disease could start receiving a new drug that slows the progression of their condition next year.

Lecanemab’s success was hailed as a “historic moment” after landmark trials showed it could halt declines in memory and thinking among patients in the early stages.

The drug, given as an injection, is designed to remove the buildup of amyloid — toxic plaques in the brain that are thought to cause the cruel memory-stealing disease.

Experts said today that the drug could be available to UK patients by 2023.

‘It depends on the regulatory authorities,’ said Professor John Hardy, a world-leading dementia researcher and molecular biologist at University College London.

But I think we will see the first people [getting the drug] Towards the end of next year.

However, doctors have warned that only one in 20 patients will benefit from treatment because the NHS dementia service is so under-resourced.

Prof Hardy has also called for middle-aged Brits to be routinely screened for Alzheimer’s disease, similar to current cervical cancer screenings for women, to identify those who could benefit from treatment.

Almost 1 million Britons and 7 million Americans suffer from dementia – and up to three-quarters of cases are thought to be caused by Alzheimer’s disease.

An experimental Alzheimer's disease drug, called lecanemab, significantly slowed cognitive and functional decline by 27 percent in a large patient trial.  Pictured: a brain scan of a person with Alzheimer's disease

An experimental Alzheimer’s disease drug, called lecanemab, significantly slowed cognitive and functional decline by 27 percent in a large patient trial. Pictured: a brain scan of a person with Alzheimer’s disease

The drug, created by Japanese pharmaceutical company Eisai and US biotechnology company Biogen, has been created to treat mild cognitive impairment in patients with amyloid in the brain.

The drug, created by Japanese pharmaceutical company Eisai and US biotechnology company Biogen, has been created to treat mild cognitive impairment in patients with amyloid in the brain.

Everything you need to know about the Alzheimer’s drug ‘breakthrough’ lecanemab

What do you do, or what do you do?

Lecanemab is a drug that is injected twice a week for those with early-onset Alzheimer’s disease.

The antibody treatment, pioneered by Japanese and American drug giants Eisai and Biogen, fights the buildup of plaque in the brain, which is believed to be behind Alzheimer’s disease.

What did the trials show?

A phase III trial of lecanemab evaluated the drug’s ability to reduce cognitive and functional decline among 1,795 patients with early-onset Alzheimer’s disease.

Half of the participants were given 10 mg/kg of the drug twice a week, while the others were given a placebo.

The researchers measured the participants’ memory, judgment, problem-solving, and judgment before they started taking the drug or placebo and again 18 months later.

The results showed that those treated with lecanemab experienced a 27 percent lower mental state decline than those given a placebo.

The scans showed that the likanimab group also had a slower buildup of amyloid levels in the brain.

Are drugs dangerous?

In addition to the promising results, clinical trials have also indicated safety concerns.

Brain swelling and microbleeding were observed between 21.3 percent in the licanimab group and 9.3 percent in the placebo group.

The pharmaceutical giants said the numbers were within the expected range.

One patient in the United States while taking licanimab during clinical trials has reportedly died, after suffering a brain hemorrhage.

However, Eisai and Biogen point out that all available safety information shows that the treatment is not associated with an increased risk of death.

How close is he to bringing it up?

The drugmakers are seeking approval for lecanemab from the US Food and Drug Administration, with a decision expected in early January.

The companies say they will also submit their results to regulators in Japan and Europe by April 2023.

However, monitors will then need to assess whether the drug is safe and effective before making a decision, so it is not clear when treatment might be started.

How does it differ from a similar drug Aduhelm?

Aduhelm and lecanemab — both made by Eisai and Biogen — are antibodies designed to clear amyloid deposits.

However, lecanemab targeted amyloid that had not yet clumped together, while Aduhelm removed amyloid plaques that had built up in the brain.

Aduhelm’s approval has been a rare bright spot for Alzheimer’s patients, but critics have warned of the drug’s underwhelming results and highlighted its risks.

Results from the full trial of lecanemab are scheduled to be presented at a dementia conference in San Francisco next week.

Early highlights showed that they slowed the progression of symptoms by 27 percent over 18 months and saw a slower buildup of amyloid levels in the brain.

The drug, created by Japanese pharmaceutical company Eisai and US biotech company Biogen, was created to treat mild cognitive impairment in patients with amyloid in the brain.

There are two ways to detect amyloid on the brain – a brain scan or a biomarker test.

The latter is currently done through a lumbar puncture, when a thin needle is inserted between the bones in the lower spine.

Both tests are expensive and there are currently long waiting times, with problems compounded by the standard NHS backlog.

And they don’t necessarily prove that a patient has Alzheimer’s disease, as doctors have to make a diagnosis after a battery of memory, concentration, and communication tests.

Experts said that while private patients and those who live near major dementia services have access to these diagnostic tests, the vast majority of the public cannot.

Without major changes to the NHS diagnostic services, patients initially eligible for lecanemab – who must be in the early stages of Alzheimer’s disease – may not meet these criteria by the time testing is due, they fear.

Experts are excited about the results of recent trials of amyloid drugs and say they are optimistic “that we are seeing the beginnings of Alzheimer’s treatments”.

But they warned that using Lecanemab in the UK would be “hard work”.

Speaking ahead of the Alzheimer’s Clinical Trials Conference, Dr Suzanne Koolhaas, Research Director at Alzheimer’s Research UK, said: “The lecanemab results bring a renewed sense of urgency to improve the way we diagnose diseases such as Alzheimer’s.”

Dr Liz Coulthard, Associate Professor of Dementia Neuroscience at the University of Bristol and North Bristol NHS Trust, added: ‘Over the years, as a profession, we haven’t used the biochemical definition of Alzheimer’s because we haven’t been able to test it until after people are dead.

But we now have biomarker tests that have entered the clinical field in the last five years or so that we can accurately diagnose people with Alzheimer’s disease.

So if you work in a clinic where there are no biomarkers, the accuracy of diagnosing Alzheimer’s is about 70% — we can’t properly diagnose Alzheimer’s without biochemical tests.

“This wasn’t a priority because there were no molecular therapies, but now that there are, we need to start doing biochemical testing on everyone.”

She added that the “vast majority of people” do not receive a vital sign diagnosis, and there is “a huge gap between current service provision and what we need to do to deliver disease-modifying therapies.”

Dr Mani Santana Krishnan, Chair of Geriatrics at the Royal College of Psychiatrists, added: “We need to prepare.

“It’s about staffing our existing memory services with a strong, technologically advanced staff.”

But Prof Hardy said there was precedent for the NHS to adapt quickly to new treatments – pointing to the start of treatment for multiple sclerosis.

Dr. Coulthard estimated that only five percent of patients will receive licanimab and most will have private access to vital sign testing.

Dr Liz Coulthard, associate professor of dementia neuroscience at the University of Bristol and North Bristol NHS Trust, has estimated that only five per cent of patients will receive lecanemab and most will have private access to a vital sign test.

Professor John Hardy, a world-leading dementia researcher and molecular biologist at University College London, said the drug may be available to UK patients as early as 2023.

Dr Liz Coulthard (left), associate professor of dementia neuroscience at the University of Bristol and North Bristol NHS Trust, has estimated that only five per cent of patients will get licanimab and that most will get a vital sign test. Professor John Hardy (R), a world-leading dementia researcher and molecular biologist at University College London, said the drug could be available to UK patients as early as 2023.

‘There are a few clinics in big cities that are doing vital sign tests now,’ she said.

It would be a small percentage of those who could qualify, unless something changes.

Or what will happen is we’ll have long waiting times, but the problem is people will wait after that… I guess it won’t get licensed in a mean illness.

“So people will be on a waiting list and by the time they come to see us, they will be very far advanced for the disease, which would be a terrible thing.”

Professor Hardy said people should be called in for a vital signs test on their 60th birthday.

This will detect those with early signs of amyloid buildup and ‘focus attention’ for treatment on those who already have some evidence of dementia.

However, Dr Coulthard warned the idea of ​​screening middle-aged Brits for dementia when they have no signs of the disease would only ‘really enter the field’ if current trials in asymptomatic people with evidence of amyloid prove successful.

‘Right now, I think it’s quite controversial,’ she said, ‘unless you knew what you were going to do on the basis of that positive result for amyloid, if it were asymptomatic.

Because there is a huge psychological burden [on the patient].

Dr. Coulthard: Even diagnosing people in MCI — if we get a license for lecanemab or another similar drug, it’s going to be necessary to diagnose people. [when symptoms are mild].

“The psychological impact of that we have to think about as well. That’s a big thing for people — it’s many years of life with this diagnosis.

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