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News about the side effects of the drug crucial to the future of hundreds of thousands of Alzheimer’s patients in the UK is due to be released next week.
It’s been three decades since scientists began investigating new ways to tackle the brain-wasting disease that is the most common cause of dementia.
Finally, earlier this year, there was a breakthrough when the drug Lecanemab showed a small but clear effect on memory loss – the first time it had done so. After 18 months, it slowed the progression of Alzheimer’s disease by 27 percent compared to patients taking the placebo.
But there is a long way between a successful trial and a drug available on the NHS. Details on a potential major hurdle for Lecanemab will be released at the Clinical Trials in Alzheimer’s Disease (CTAD) conference, which begins in San Francisco on Tuesday.
The problem is the discovery that a prominent side effect of Lecanemab can be small areas of swelling or bleeding in the heart. Most of the time it was asymptomatic. But about 3 percent of the time there were symptomatic changes in the brain due to the drug.
Patients in the trial had regular MRI scans for brain swelling and bleeding. But this is something that many NHS hospitals dealing with huge Covid delays and staff shortages will not be able to provide. Lecanemab is also difficult to administer as patients are required to attend the clinic for an intravenous infusion twice a month.
More will become clear at next week’s conference when the drug’s manufacturers – Tokyo-based pharmaceutical company Eisai and US biotech firm Biogen – will present their full clinical trial results.
If the side effects require constant monitoring, there is a chance that the National Institute for Health and Care Excellence, which must approve the use of any new drug on the NHS in England and Wales, could refuse Lecanemab for reasons of cost given the huge number of people with Alzheimer’s disease in the UK. It is not yet clear exactly what the drug can do for patients.
Dr Liz Coulthard, associate professor of dementia neurology at the University of Bristol, who also works at North Bristol NHS Trust, said: “What we don’t know yet is how serious the side effects were in this trial and will it really be interesting. to look for [in the conference next week].
“The other very important thing for us clinically is that we can tell in advance who will get these brain changes? That will help us a lot with targeted therapy and also counseling people before therapy. We are really excited about these therapies that modify the disease, like our patients”.
The drug is the culmination of three decades of research after the “amyloid hypothesis”, which originated in the early 90s: researchers believe that the primary cause of Alzheimer’s is defects in the processes that govern the production, accumulation or elimination of a microscopic fragment of brain protein called. beta-amyloid.
Potential new drugs
Lecanemab:
It targets amyloid to slow the progression of Alzheimer’s. Interim results shared on September 27 show that the drug reduced cognitive decline by 27 percent, with scientists describing it as a “historic moment.” Full clinical results will be announced on Tuesday at 12:50 UK time
Gantenerumab:
It targets amyloid to slow the progression of Alzheimer’s. Interim results on November 14 revealed that it has not been shown to reduce cognitive decline, but the data will be valuable for future research trials. Researchers therefore believe that all is not lost. Full clinical results are out at 12.15pm UK time on Wednesday.
Brexpiprazole:
A proven antipsychotic medication for agitation for people living with Alzheimer’s. The interim results of June 27 show that the agitation reduced. Full clinical results are due at 7.20pm UK time on Thursday.
Even if the side effects are shown to be not as severe as some doctors fear, many obstacles remain before NHS patients can not only access Lecanemab, but also be given in ime to make a difference. Dr. Coulthard said that the dementia patients he sees are usually well into the course of their illness and it is therefore too late for any treatment to help.
“Patients really want and deserve better dementia treatments,” he added. “We often don’t see people with mild disease because they tend to be reassured by their GPs until their symptoms are really impressive.
“For these drugs to work on patients, we also need to know if the patients have amyloid in their brain. We can do that. In my clinic we do lumbar punctures to look for amyloid and we can also do PET scans [positron emission tomography scans, which produce detailed three-dimensional images of the inside of the body].
“But under 1 per cent of patients seen in dementia clinics in the UK have this kind of accurate diagnosis that actually shows they have amyloid. So we’re seeing patients too late.”
Experts also warn that unless there are major changes in diagnostic services, people could be ineligible for Lecanemab treatment while on the waiting list for diagnosis because it can only be given to patients with mild diseases .
Last year, there was an average wait of 17.7 weeks between referral and diagnosis of dementia, with some waiting two whole years.
If patients’ disease progresses to a moderate stage while on the waiting list, they will no longer be eligible for treatment. Only 5 percent of patients eligible for the drug will be able to access it and most of these will be private cases, according to one estimate.
Fiona Carragher, director of research and advocacy at the Alzheimer’s Society, said: “To give these drugs the best chance of working, the health system needs to be able to diagnose people with Alzheimer’s as early as possible in the progression of the disease. his illness
“However, due to the pandemic, there is a significant lag in memory assessment services, which means dementia diagnosis rates are still below target.
“Unless dementia diagnosis rates improve, people will be denied access to potentially life-changing drugs if and when they become available.
“We need to give people a specific diagnosis, so they know if they have Alzheimer’s -= and potentially could benefit from drugs like Lecanemab – or another type of dementia. Now, memory services report diagnosing between 7 and 82 percent of people with Alzheimer’s disease – there is a large variation.
More on Alzheimer’s disease
Lecanemab is now licensed in the United States, which will help UK doctors to see the appropriate usage guidelines and begin to understand to whom they should give the drug and what side effects there might be.
However, the UK health system is currently set up to keep people with early symptoms out of hospitals, making it difficult for a drug like Lecanemab to reach the right people. The NHS has also suggested that the earliest we could see these drugs being used is 2026.
Despite the possible difficulties involved in the effective use of the drug, researchers are positive about the progress made and what they will learn next week.
“I’m really excited about the work that’s going to be presented [in San Francisco]”said Professor Sir John Hardy, chair of molecular biology of neurological diseases at the UCL Institute of Neurology – whose research first discovered the role of amyloid as a cause of Alzheimer’s disease .
“I’m excited because I spent $7,000 of my own lab budget to attend, because I want to be there and see this in person. I really think this is a historic moment. It took a long time to get her
“I am optimistic that we will see the beginning of Alzheimer’s therapies. [But] putting this into clinical practice will be hard work.
“The other thing we don’t know is if this works, we can give the drug, it beats the amyloid [levels] right down and then just monitor that for several months and visit again if the amyloid starts to grow. It would be great news, because it would reduce the cost of therapy. This will be a real challenge for the NHS.”
Ms Carragher said: “Dementia needs to be seen as a priority in the NHS, and we need the promised 10-year plan for dementia – including details of how the NHS will get diagnosis up to scratch and prepare for new dementia drugs – to do this. happen.”
The Government said the plan would be published “later this year”. Officials said the Government is focusing on how new medicines and emerging science and technology can be harnessed to improve outcomes for dementia patients across the country.
For now, all eyes will be on San Francisco. Dementia experts are all too aware of the number of amyloid therapies that haven’t worked, but they remain optimistic.
Sir John said: “If the results are positive next week, a drug like Lecanemab becoming available on the NHS would be a massive triumph. But there will be challenges in getting drugs to the right people at the right time – we need changes in the infrastructure of our health system to ensure that we are ready if we see the results we hope for.”
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