News about the side effects of drugs critical to the future of hundreds of thousands of Alzheimer’s sufferers in the UK will be published next week.
It’s been three decades since scientists began exploring new ways to combat the brain-wasting disease that is the most common cause of dementia.
Finally, there was a breakthrough earlier this year when the drug lecanemab showed a small but significant effect on memory loss – the first time anyone has done it. After 18 months, ti slowed the progression of Alzheimer’s by 27 percent compared to patients taking a placebo.
But there is a long way to go between a successful trial and a drug provided by the National Health Service. Details of a potential key barrier to lekanemab will be made public at the Alzheimer’s Disease Clinical Trials (CTAD) conference starting Tuesday in San Francisco.
The problem lies in the discovery that a noticeable side effect of lekanemab can be a slight swelling or bleeding in the brain. It was usually asymptomatic. But in about 3 percent of cases, there were symptomatic changes in the brain due to the drug.
Patients in the study had regular MRI scans to detect cerebral edema and bleeding. But it’s something that many NHS hospitals, facing massive Covid delays and staff shortages, simply can’t offer. Lecanemab is also difficult to administer because patients must visit the clinic twice a month for intravenous infusion.
More will become clear at a conference next week, when the drug’s makers, Tokyo-based pharmaceutical company Eisai and US biotech company Biogen, will present the full results of their clinical trials.
If side effects must be constantly monitored, there is a chance that the National Institute for Health and Excellence, which in England and Wales is responsible for NHS approval of new drugs, may reject lekanemab due to the huge cost to a large number of people. with Alzheimer’s disease in the United Kingdom. It is also unclear what effect the drug may have on patients.
Dr Liz Coulthard, Associate Professor of Dementia Neurology at the University of Bristol, who also works for the North Bristol NHS Trust, said: “What we don’t know yet is how severe the side effects were in this study and that will look very interesting.” for researchers. pass [in the conference next week].
“The other thing that’s really important for us from a clinical standpoint is that we can tell ahead of time who will have these brain changes? This will help us a lot in targeted therapy as well as pre-therapy counseling. We are very excited about these disease-modifying therapies, as are our patients.
The drug is the result of three decades of research under the “amyloid hypothesis” that emerged in the early 1990s: researchers believe that the main cause of Alzheimer’s disease is defects in the processes that control the production, accumulation or removal of a microscopic brain protein. fragment called beta-amyloid.
Potential new drugs
Lecanemab:
Acts on amyloid to slow the progression of Alzheimer’s disease. Interim results, released September 27, show the drug reduced cognitive decline by 27 percent, in what scientists called a “historic moment.” Full clinical results will be announced Tuesday at 12:50 UK time.
Gantenerumab:
Acts on amyloid to slow the progression of Alzheimer’s disease. Interim results from November 14 showed that it does not reduce cognitive decline, but the data will be useful for future research trials. Therefore, researchers believe that not all is lost. Full clinical results Wednesday at 12:15 pm UK time.
Brexpiprazole:
An antipsychotic drug that has been tested for agitation in people with Alzheimer’s disease. Interim results as of June 27 showed a decrease in unrest. Full clinical results Thursday at 7:20 pm UK time.
Even if the side effects turn out not to be as severe as some doctors fear, there are still many hurdles before NHS patients not only have access to lekanemab, but get it in time to make a difference. Dr. Coulthard said that the dementia patients she sees are usually in the advanced stages of the disease and therefore it is too late for any treatment to help them.
“Patients really want and deserve the best treatment for dementia,” she added. “We often don’t see people with a mild illness because the family doctor usually reassures them until the symptoms are really noticeable.
“For these drugs to work in patients, we also need to know if patients have amyloids in their brains. We can do it. At my clinic, we do a lumbar puncture to look for amyloid, and we can also do a PET scan. [positron emission tomography scans, which produce detailed three-dimensional images of the inside of the body].
“But less than 1% of patients seen in UK dementia clinics have a diagnosis that is so accurate that it actually shows that they have amyloid. Therefore, we accept patients too late.”
Experts also warn that people who are on a diagnostic waitlist may not be eligible for treatment with lekanemab unless there is a major change in diagnostic services, as it can only be given to patients with mild disease.
Last year, an average of 17.7 weeks elapsed between referral and a diagnosis of dementia, with some waiting years.
If a patient on the waiting list progresses to the intermediate stage, they are no longer eligible for treatment. According to one estimate, only 5% of eligible patients will have access to the drug, and most of these will be special cases.
Fiona Carragher, director of research and advocacy for the Alzheimer’s Society, said: “To give these drugs a better chance of being effective, the healthcare system needs to be able to diagnose Alzheimer’s in people as early as possible in the disease process.
“However, due to the pandemic, there is a significant backlog in memory assessment services, meaning that dementia diagnosis rates are still below targets.
“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 that they know if they have Alzheimer’s disease —= and whether drugs like lecanemab — or some other form of dementia can potentially help. Right now, memory services are reporting that between 7 and 82 percent of people are diagnosed with Alzheimer’s – a huge difference.”
Lecanemab is now approved in the United States, which will help UK physicians understand recommendations for proper use and understand who should be given the drug and what side effects may occur.
However, the UK health system is currently focused on keeping people with early symptoms out of hospitals, making it harder for drugs like lecanemab to get to the right people. The National Health Service also suggested that the earliest use of these drugs is 2026.
Despite the potential problems with the effective use of the drug, the researchers are confident in the progress being made and what they will learn next week.
“I am very excited about the works presented at the exhibition. [in San Francisco]said Professor Sir John Hardy, Chair of the Molecular Biology of Neurological Disorders at the University of California Institute of Neurology, whose research is the first to reveal the role of amyloid in Alzheimer’s disease.
“I’m happy with how much I spent $7,000 of my own lab budget on participation because I want to be there and see it in person. I really think this is a historic moment. It took a long time to catch her
“I am optimistic that we are seeing the beginning of a therapy for Alzheimer’s. [But] bringing this into clinical practice will be hard work.
“Another thing we don’t know is that if this works, we might be able to give a drug that knocks down amyloid. [levels] all the way down and then watch it for a few months and check again when the amyloid starts creeping up. This would be great news because it will reduce the cost of therapy. This will be a real test 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 update the diagnosis and prepare for new dementia drugs to achieve this. ”
The government said the plan would be published “later this year”. Officials said the government will focus on how new drugs and the latest advances in science and technology can be used to improve outcomes for patients with dementia across the country.
For now, all eyes will be on San Francisco. Dementia experts are all too aware of how many amyloid therapies have failed, but they remain optimistic.
Sir John said: “If the results are positive next week, then a drug like lekanemab that becomes available on the NHS will be a huge triumph. But there will be challenges in getting medicines to the right people at the right time – we need changes to our healthcare system infrastructure to be ready when we see the results we hope for.”
Source: I News
I’m Raymond Molina, a professional writer and journalist with over 5 years of experience in the media industry. I currently work for 24 News Reporters, where I write for the health section of their news website. In my role, I am responsible for researching and writing stories on current health trends and issues. My articles are often seen as thought-provoking pieces that provide valuable insight into the state of society’s wellbeing.