The fight against curing Alzheimer's has made a huge milestone after a new drug reduced memory decline among patients.
Lecanemab was designed to target and clear amyloid - one of the proteins that build up in the brains of people with Alzheimer's. Experts are hailing the treatment as the "beginning of the end" in searching for effective treatment for the illness.
Phase three clinical trial results were reported by Eisai, a Tokyo-based pharmaceutical company that partnered with US biotech firm Biogen to develop lecanemab. Eisai reported initial results in September from a trial involving 1,795 participants with early Alzheimer's disease.
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In the report, scientists found that, after 18 months, the drug slowed the progression of the disease by 27 per cent compared to patients who took a placebo. Full results from the study have been published in The New England Journal of Medicine.
“This trial is an important first step, and I truly believe it represents the beginning of the end,” said Professor John Hardy, group leader at the UK Dementia Research Institute at University College London.
“The amyloid theory has been around for 30 years so this has been a long time coming. It’s fantastic to receive this confirmation that we’ve been on the right track all along, as these results convincingly demonstrate, for the first time, the link between removing amyloid and slowing the progress of Alzheimer’s disease.
“The first step is the hardest, and we now know exactly what we need to do to develop effective drugs. It’s exciting to think that future work will build on this, and we will soon have life-changing treatments to tackle this disease.”
Prof Bart De Strooper, director at the institute, added: “The overall conclusion is extremely positive. This trial proves that Alzheimer’s disease can be treated.”
Prof Nick Fox, director of the Dementia Research Centre, said: “I believe, it confirms a new era of disease modification for Alzheimer’s disease. An era that comes after more that 20 years of hard work on anti-amyloid immunotherapies – by many many people – and many disappointments along the way.”
Dr Richard Oakley, associate director of research at Alzheimer’s Society, said the results had the potential to be “game-changing”. He said: “They give us hope that in the future people with early Alzheimer’s disease could have more time with their loved ones."
Despite the promising signs, UK officials have warned there is much to do before they can deliver the drug, provided it receives regulatory approval. There are two ways to tell whether there is amyloid in the brain - by either using a brain scan or biomarker test.
While there are signs a blood test could soon be in the works, dementia services are still relying on current testing methods which are timely and expensive. Private patients living near large dementia services can have easy access to these diagnostics, but the majority of the public cannot, according to experts.
They also warned testing services must change or many may be unable to receive lecanemab treatment while on the waiting list since the drug can only be given to patients with mild Alzheimer's. If their disease progresses while they're on the waiting list, they will no longer be eligible for the treatment.
Prof De Strooper said: “The participants of this trial were all people with very early-stage Alzheimer’s disease, which raises the question of how we ensure that people can access these drugs at the right stage in their disease course.
“In parallel, we must focus on making early diagnosis easier and more accessible, so that treatments can be administered when they are most likely to have a positive impact, before amyloid levels are too high and start to cause damage to the brain.”
Experts have also highlighted that more work needs to be done on investigating the side effects of the drug. “The trial results have shown us that there is a risk of side effects, including brain bleeds in a small number of cases,” Prof Hardy said.
“This doesn’t mean the drug can’t be administered, but that will be important to have rigorous safety monitoring in place for people receiving lecanemab, and further trials to fully understand and mitigate this risk.”
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