A huge step forward in dementia research has been hailed a truly historic moment by researchers working to find a cure for people with Alzheimer’s Disease. This is the first time a drug being trialed, lecanemab, has shown a reduction in the disease in the brain while slowing memory decline.
Dr Susan Kohlhaas, director of research at Alzheimer’s Research UK, said: “These exciting findings represent a major step forward for dementia research and could herald a new era for people with Alzheimer’s disease.
Lecanemab slowing the course of Alzheimer’s
“Lecanemab works by clearing the amyloid protein that builds up in the brain in people with Alzheimer’s disease. In this trial, the drug slowed down participants’ decline in memory and thinking, and their ability to carry out day-to-day activities. Although the benefits were small and came with significant side effects, it marks the arrival of a treatment that can slow the course of Alzheimer’s disease.”
However, she cautioned that with all the excitement, there are still many questions and challenges that need to be addressed.
“The treatment window in the trial was for 18 months, so we don’t yet know whether there will be impacts to people that last beyond this. Longer-term studies that are ongoing will tell us whether the modest improvements seen in the trial change the trajectory of the disease longer-term,” she added.
Severe side effects for lecanemab
Researchers found that lecanemab was associated with severe side effects so it will be vital for regulators to understand the safety profile of the drug before it is given a full license.
Kohlhaas said the benefits of taking lecanemab in the trial were modest, but the challenge and opportunity remains within dementia research to build on these findings into an era where multiple treatments against different aspects of Alzheimer’s are developing to slow and stop the disease.
“It’s safe to say that the NHS is not ready for a new era of dementia treatments. We estimate that unless there are drastic changes in how people access specialist diagnostic tests for Alzheimer’s disease, only 2% of people eligible for drugs like lecanemab will be able to access them.
NHS unable to deliver Alzheimer’s drug
According to researchers, the NHS is unable to deliver lecanemab because it does not have sufficient diagnostic tests to identify the patients most likely to benefit. There are, simply put, not enough staff to give all patients in need of treatment an infusion of the drug every two weeks nor can it provide the multiple MRI scans needed to monitor any side effects including haemorrhaging or brain swelling.
Kohlhaas said Alzheimer’s researchers recommend, through the new Dementia Mission, the government take urgent steps to bring together regulators, industry, clinicians and decision-makers in our health system to put a clear plan in place to ensure people in the UK are among the first in the world to access new treatments once they are licensed.
“This is truly a historic moment for dementia research. This year is the 30th anniversary of the seminal work that revealed the central role of amyloid protein in Alzheimer’s. The road to an anti-amyloid treatment has been a long one and people with Alzheimer’s have seen many disappointing setbacks. We hope that this drug will make it to patients, but it won’t be suitable for everyone with Alzheimer’s, and it’s only a first step on the journey towards a cure” she concluded.
Trial deaths – not related to lecanemab
Published in the report, 13 people died while taking part in the trial – of those, six had received the drug and seven had received placebo. None of the deaths were considered by the investigators to be related to the drug.
Dr Richard Oakley, associate director of research at the Alzheimer’s Society, said these results offered the “best hope yet delaying symptom progression for people with early-stage Alzheimer’s.” He said significantly, the results indicated slowing the loss of quality of life for them and their families – and, their carers.
Hugely promising for Alzheimer’s sufferers
He said they highlight more than ever the need to prioritize early diagnosis, through wider access to PET brain scans and research to get blood tests into the clinic, so people can access these drugs when they become available.
New, early modelling data from this trial suggests the drug could delay decline of memory and thinking skills of people with mild Alzheimer’s by more than seven months.
He said: “We also heard new data shows lecanemab could slow down decline in quality of life for patients and carers by up to 56%. This is hugely promising and gives us hope that those affected by Alzheimer’s disease could have more quality time as a family.
Not the end of the journey
“Our research led by Sir John Hardy over thirty years ago seeded trials like this by discovering the importance of amyloid protein in Alzheimer’s disease. It laid the foundations for billions of pounds of investment into many of the drugs like lecanemab, with 117 other drugs currently in trials.
“This isn’t the end of the journey for lecanemab – it’s being explored in further trials to see how well it works over a longer period of time and the difference it could make to people before their symptoms have even developed.”
He said there is still a long way to go before lecanemab could be available on the NHS, and there will be a wait for clarity for how and when the approval process will take place in the UK, and whether regulators believe it is cost-effective.
Lecanemab: only for those with early Alzheimer’s
Oakley added: “We mustn’t forget that lecanemab can only be given to people with early Alzheimer’s disease who have amyloid in their brain. This means people with other types of dementia, or in the later stages of Alzheimer’s disease, can’t benefit from this drug.
“We were excited to see a recommitment to the National Dementia Mission on Monday. This crucial doubling of dementia research funding must be delivered urgently. With 900,000 people living with dementia in the UK, this crucial investment must boost research for all types of dementia so no one is forgotten.”
The drug is jointly being developed by Eisai Co. Ltd. and Biogen.