A new drug which has been shown to slow cognitive decline in Alzheimer’s will be ‘welcome news’ for millions of patients, say experts, but there is still some way to go.
Positive results on the efficacy of the amyloid-clearing drug, lecanemab, have been published this week, representing a major starting point for Alzheimer’s treatment.
The findings, which showed the drug was able to slow cognitive decline in patients with Alzheimer’s by 27 per cent, have been described as a ‘breakthrough’ and ‘welcome news’ for the millions families affected by the condition.
Alzheimer’s disease is a progressive neurological disorder that severely impacts people living with the condition and their loved ones.
With the increased global aging population, the disease has become a critical issue for society and healthcare systems and new therapeutic agents that act on the disease pathology are needed.
While there is no cure yet, treatment goals for early Alzheimer’s are to have sustained effects on cognitive function, activities of daily living and psychiatric symptoms, to maintain independence longer by slowing progression of the disease and to improve or maintain quality of life.
In a double-blind placebo trial involving over 1,700 participants, Llecanemab demonstrated consistency of results across scales of cognition and function, showing a 31 per cent lower risk of converting to the next stage of disease.
An analysis of the data showed that lecanemab takes 25.5 months to reach the same level as placebo at 18 months, indicating a seven and half month slowing of progression.
Modeling simulations based on the phase 2 trial data suggest that lecanemab may slow the rate of disease progression by up to three years and has the potential to help people remain in the earlier stages of the disease for a longer period of time.
In addition, it was shown to maintain the health-related quality of life and reduce the burden on caregivers by 25 – 30 per cent.
Lecanemab is poised for FDA approval early next year.
‘Welcome news but more ground to cover’
The study results were presented at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference and published in The New England Journal of Medicine on Tuesday.
Responding to the findings, the Alzheimer’s Drug Discovery Foundation (ADDF) welcomed the developments, but says a combination drug approach is needed.
“Today’s results show that lecanemab slows cognitive decline, which is welcome news for the millions of patients and families living with Alzheimer’s,” said Dr Howard Fillit, Co-Founder and Chief Science Officer at the ADDF.
“But this is only a start to stopping Alzheimer’s in its tracks. We have a lot of ground to cover to get from the 27 per cent slowing lecanemab offers to our goal of slowing cognitive decline by 100 per cent.”
Amyloid-clearing drugs are one part of the solution, but there remains a pressing need to develop a new generation of drugs targeting all aspects of the biology of aging that can be combined to address the full array of underlying pathologies that contribute to the disease.
New and emerging easy-to-use diagnostic tools like those supported by the ADDF’s Diagnostics Accelerator can help pinpoint the specific underlying causes of each person’s Alzheimer’s, enabling precision treatment approaches and improving clinical trials.
“Unique drug combinations matched to each patient’s underlying pathologies is the answer, and our best hope to give patients long-lasting relief from this insidious and progressive disease,” said Dr Fillit.
Today’s Alzheimer’s drug pipeline is more robust than ever, with 75 per cent of drugs currently in clinical trials aimed at novel targets beyond amyloid and tau according to a recent report.
“Today’s news is encouraging for everyone who has worked on lecanemab and for those of us who have spent decades tackling Alzheimer’s by improving clinical trial designs,” said Dr Fillit.
“But even more, this is proof that our research is paying off. It gives us a clear vision of a day soon when treatments will allow patients to maintain their independence not just for weeks or months more, but for years more and perhaps for their lifetimes.”
