Representative groups for people with dementia have hailed as potentially “historic” the results of clinical trials which show that a new drug may reduce memory decline in patients in the early stages of the disease.
After an 18 month period, cognition of Alzheimer’s patients who were given the drug declined by 27% less than those on a placebo treatment. The breakthrough is considered to be significant because this is the first time any drug has been clearly shown to alter the trajectory of the disease in clinical trials.
The drug, Lecanemab, was used in clinical trials organised in a collaboration between Eisai, a Tokyo-based pharmaceutical company and a US biotech firm Biogen. Eisai this month reported results from the trials involving 1,795 participants with early-stage Alzheimer’s.
The Alzheimer Society of Ireland welcomed what they said were “encouraging top-line results”, describing the clinical trial outcomes as “exciting news”.
The ASI Research and Policy Manager, Dr Laura O’Philbin, said: “This announcement is very positive and encouraging following years of failed treatment development attempts. Scientifically, this is a landmark development, and we look forward to understanding more about the potential impact of this treatment in practice when there is a complete picture of the data in November. This is a positive day for the future of dementia and we look forward to continuing to support people affected by dementia in the present.”
Dr Sean Kennelly, Director of Clinical Research Memory Service at Tallaght University Hospital and Clinical Associate Professor at Trinity College Dublin, said: “This is very exciting news, and we are moving into a zone that we have aspired to for some time where we can identify definitive treatments to treat and prevent Alzheimer’s Disease. We await specific details on outcomes, but this initial topline information is very promising and brings great encouragement to people across Ireland and indeed the world.”
Elsewhere the results were described as historic.
“This is a historic moment for dementia research, as this is the first phase 3 trial of an Alzheimer’s drug in a generation to successfully slow cognitive decline,” Dr Susan Kohlhaas, the director of research at Alzheimer’s Research UK said.
“Many people feel Alzheimer’s is an inevitable part of ageing. This spells it out: if you intervene early you can make an impact on how people progress.”
“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,” she said.
Lecanemab was developed as an antibody designed to clear amyloid beta proteins, which are believed to build up in abnormal amounts in the brains of people during the early stages of Alzheimer’s disease.
The new results will doubtlessly bring fresh attention to a recent charge of falsified data in research on amyloid beta plaques which shaped the course of dementia research for decades.
The results of the Lecanemab trials have been described by Eisai as “highly statistically significant” – and will be seen as evidence that the amyloid beta plaque hypothesis may be correct.
“Alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety,” Haruo Naito, chief executive of Eisai, said.
“We believe that helping to alleviate these burdens will positively impact society as a whole.”
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” Michel Vounatsos, CEO at Biogen, said in a statement. “Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease.
More details on the research will be presented to the Clinical Trials On Alzheimer’s Congress in November, according to the pharma collaboration.
In a statement, officials at the Alzheimer’s Discovery Drug Foundation (ADDF) were more cautious, saying the findings showed “modest effectiveness,” but that they are still encouraged by the news.
“The combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s,” said Dr. Howard Fillit, the co-founder and chief science officer at the ADDF. “However, amyloid-clearing drugs will provide an incremental benefit at best and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging. We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting non-amyloid pathways of neurodegeneration.”
Among the side-effects of the medication recorded in the trial were brain swelling and tiny bleeds. The study reported that 17% of people experienced small brain bleeds, compared to 8.7% in the placebo group. The side effects were detected in brain images but rarely caused symptoms.
The Alzheimer’s Society of Ireland said that “will need to be discussions about what this might mean clinically, and in real life. People who took part in the study were in the early stages of memory problems and that is who this drug will be targeted at.”
“It’s essential that we continue to advocate for and resource other interventions and supports for people who are living with dementia today. There are currently an estimated 64,000 people with dementia in Ireland, and by 2045, that number is anticipated to increase to 150,000,” they said.
They added that the “exciting International development follows the launch of Dementia Trials Ireland, on Tuesday 27th September. Dementia Trials Ireland is funded by the Health Research Board and will create a national infrastructure to develop, attract and conduct dementia clinical trials across the State.”