Thursday, December 22, 2022

‘Patients deserve better dementia treatments’: NHS hopes for new Alzheimer’s drug

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Crucial information on the side effects of lecanemab is set to be released next week. But NHS waiting lists could still prevent sufferers from getting treatment in time

News about drug side effects, which are crucial for the future of hundreds of thousands of Alzheimer’s sufferers in the UK, are due to be released next week.

It’s been three decades since scientists began investigating new ways to fight brain wasting disease, 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 this has happened. After 18 months, ti slowed the progression of Alzheimer’s disease by 27 percent compared to patients taking the placebo.

But there is a long way to go between a successful trial and the NHS making a drug available. Details of a potential key obstacle for lecanemab will be released at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, which begins Tuesday in San Francisco.

The problem is the discovery that a prominent side effect of lecanemab can be small swelling or bleeding in the brain. Most often this was asymptomatic. But about 3 percent of the time there were symptomatic changes in the brain due to the drug.

The study patients underwent regular MRI scans for brain swelling and bleeding. But that’s just not something many NHS hospitals struggling with huge Covid backlogs and staff shortages can offer. Lecanemab is also difficult to administer, requiring patients to come to the clinic twice a month for an intravenous infusion.

More will become clear at next week’s conference, when the drug’s makers – Tokyo-based pharmaceutical company Eisai and US biotech company Biogen – will present their full clinical trial results.

If the side effects require constant monitoring, there is a chance that the National Institute of Health and Care Excellence, which has to approve the use of new medicines on the NHS in England and Wales, could reject lecanemab on cost grounds given the large number of patients with Alzheimer’s disease in Great Britain. It’s also unclear what difference the drug can make to patients.

dr Liz Coulthard, associate professor of dementia neurology at Bristol University, who also works at North Bristol NHS Trust, said: “What we don’t know yet is how serious the side effects were in this study and that’s going to be really interesting to look out for [in the conference next week].

“The other thing that’s clinically very important for us is, can we tell in advance who is going to get these brain changes? This will help us a lot in targeted therapy and also in advising people before therapy. We are really excited about these disease-modifying therapies, as are our patients.”

The drug is the result of three decades of research following the “amyloid hypothesis”, which has its origins in the early 90’s: researchers believe that the main cause of Alzheimer’s are errors in the processes that control the production, accumulation or disposal of a microscopic small brain protein fragments called beta-amyloid.

Even if the side effects turn out to be not as severe as some medics fear, there are still many hurdles before NHS patients may not only be able to access lecanemab, but get it in time to make a difference. dr Coulthard said the dementia patients she treats are usually far along in the disease process, making it too late for treatment to help them.

“Patients really want and deserve better treatments for dementia,” she added. “We often don’t see people with mild illness because they are reassured by their GPs until their symptoms are really noticeable.

“For these drugs to work in patients, we also need to know if patients have amyloid in their brains. We can do this. At my clinic we do spinal taps 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 less than 1 per cent of patients treated in dementia clinics in the UK have that kind of precise diagnosis that actually shows they have amyloid. So we see patients too late.”

Experts also warn that unless there are major changes in diagnostic services, people who are on the waiting list to be diagnosed may no longer be eligible for lecanemab treatment, as it can only be given to patients with mild disease.

Last year, an average of 17.7 weeks elapsed between the referral and the dementia diagnosis, in some cases even years.

If a patient on the waiting list progresses to a moderate stage, they are no longer eligible for treatment. Only 5 percent of eligible patients will have access to the drug, and most of those will be private cases, one estimate says.

Fiona Carragher, director of research and advocacy at the Alzheimer’s Society, said: “To give these drugs the best chance of being effective, the healthcare system needs to be able to diagnose people with Alzheimer’s as early in the disease process as possible.

“However, due to the pandemic, there is a significant backlog in memory assessment services, meaning dementia diagnosis rates are still below target.

“If dementia diagnosis rates do not 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 could potentially benefit from drugs like lecanemab — or some other type of dementia. Currently, memory services report that between 7 and 82 percent of people are diagnosed with Alzheimer’s — there’s a huge variation.”

Lecanemab is now approved in the United States, which will help UK medical professionals see appropriate usage guidelines and understand who to give the drug to and what side effects it might have.

However, the UK healthcare system is currently geared towards keeping people with early symptoms out of hospitals, making it difficult for a drug like lecanemab to reach the right people. The NHS also suggested the earliest we could see these drugs being used is 2026.

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