dementia charity has hailed a “historic moment” in Alzheimer’s research as a new drug has been found to reduce memory loss in patients with early-stage disease.
Lecanemab was found to slow the decline in participants’ memory and thinking.
Alzheimer’s Research UK said the finding was a “historic moment for dementia research” as it is the first later-stage trial of an Alzheimer’s drug “in a generation” to successfully slow cognitive decline.
The results of the phase three clinical trial have been reported by Eisai, a Tokyo-based pharmaceutical company that is collaborating with US biotech company Biogen to develop lecanemab.
Eisai reported results from a trial involving 1,795 participants with early Alzheimer’s disease.
Lecanemab is designed to target and remove amyloid, one of the proteins that accumulate in the brains of people with Alzheimer’s disease early in the disease.
Eisai was investigating the drug — an “anti-amyloid beta-protofibril antibody” — to treat mild cognitive impairment in patients with amyloid in the brain.
The pharmaceutical company reported “highly statistically significant” results.
It compared the results of people taking the drug and people taking a placebo or fake drug.
These results show that lecanemab slows the progression of memory and thinking problems in people with early Alzheimer’s, demonstrating a major breakthrough in dementia research
scientists found that after 18 months, the drug slowed disease progression by 27% compared to those taking the placebo.
The findings were clear as early as six months after the participants started taking the drug.
The company also reported differences in the build-up of amyloid in the brain in scans of participants, with those taking the drug having lower levels than those taking the placebo.
“Alzheimer’s disease not only poses a major challenge to patients and their families, but also negatively impacts society, including reduced productivity, increased social costs and disease-related anxiety,” said Haruo Naito, chief executive of Eisai.
“We believe that helping to alleviate these burdens will have a positive impact on society as a whole.”
More details about the study will be presented to the Clinical Trials On Alzheimer Congress in Nov.
Eisai said it plans to discuss the results with medical regulators with a view to applying for market approval before the end of March.
Commenting on the findings, Dr. Susan Kohlhaas, Director of Research at Alzheimer’s Research UK said: “This is a historic moment for dementia research as this is the first phase three trial of an Alzheimer’s drug in a generation to successfully slow cognitive decline.
“These results demonstrate that lecanemab slows the progression of memory and thinking problems in people with early Alzheimer’s, demonstrating a major breakthrough in dementia research.
Once the drug has been approved, it is essential that it gets to the people who could benefit from it as soon as possible
“This is the first drug shown to not only remove the build-up of a protein called amyloid in the brain, but also have a small but statistically significant impact on cognitive decline in people with early-stage disease.
“The drug can also cause significant side effects, which must be taken into account.
“These top results, announced by the pharmaceutical company that makes the drug Eisai, offer new hope to people affected by this cruel and devastating disease.
“Before a drug is made available, regulators in various parts of the world, including the UK, will still need to review the full data to determine whether lecanemab is safe and effective enough to be used in people with Alzheimer’s disease.
“If the drug is approved, it is essential that it gets to the people who can benefit as soon as possible.
This is an unequivocally statistically positive result and represents something of a historic moment when we see the first convincing change in Alzheimer’s disease. God knows we’ve waited long enough for this
“Today’s results were only possible thanks to the volunteers who took part in this trial, previous studies on this drug, and wider research on dementia around the world.
“This drug has only been tested for people in the early stages of Alzheimer’s disease and will not be a panacea for all causes of dementia.
“We hope today’s news will lead to renewed investment in dementia research around the world and political leadership to deliver the funding and infrastructure needed to realize life-changing new treatments.”
Of the people who experienced side effects, the most common were headaches and swelling in the brain, known as “amyloid-related imaging abnormalities.”
dr. Richard Oakley, associate director of research at Alzheimer’s Society, added: “This research could play a groundbreaking role in the treatment of Alzheimer’s disease.
“For decades, people with Alzheimer’s disease have been desperately waiting for a drug to slow the progression of the disease, so this exciting news is a real breakthrough moment in dementia research.”
Commenting on the study, Dr. Catherine Mummery, consultant neurologist at the National Hospital for Neurology and Neurosurgery, said the results are “exciting” and added: “If the full details of the study are confirmed, they are the clearest indicator to date that the amyloid content in the brain may slow cognitive decline.
“The results are consistent in size with those found in previous phase trials with other anti-amyloid drugs, and with the positive, controversial trial with aducanumab. This convergence reinforces the findings. However, the magnitude of the effect, while significant, is small – the disease is delayed by 27% in 18 months. What we don’t know yet is whether that effect increases in an individual over time; that would have been predicted, but has not been tested – time will tell.”
Rob Howard, professor of psychiatry of old age, University College Londonadded: “This is an unequivocally statistically positive result and represents something of a historic moment when we see the first convincing change in Alzheimer’s disease.
“God know, we have waited long enough for this.”
dr. Liz Coulthard, associate professor of dementia neurology at the University of Bristol, added: “This is a gold standard study in people with fairly early signs of Alzheimer’s disease.
“Although not curative, lecanemab slowed the decline in daily functioning compared to placebo. Lecanemab thus potentially offers an extended quality of life for people with early signs of Alzheimer’s disease.
“Until now, many people have not come forward when they first started worrying about their memory because there were no treatments for dementia.
“It is very likely that now more people will come to their doctor – and we, as doctors, have to be ready. Most people with mild memory symptoms will not have Alzheimer’s disease. We need to develop an effective and rapid triage system so that we can reassure people without Alzheimer’s and provide treatment for people with Alzheimer’s.
“Our health system moved impressively quickly to deliver trials and therapies for Covid. Let’s hope we can apply the same efficiency to people with Alzheimer’s disease.”