Wednesday’s full data was praised by experts as showing that a new drug can slow down cognitive decline. Alzheimer’sThe treatment was not a success for all patients.
In September, preliminary data from a trial with lecanemab were released. They found that it slows cognitive decline by 27 per cent over an 18-month period.
The complete trial data Publié in New England Journal of MedicineThese findings are detailed in the article, which also raises concerns about the possibility of “adverse consequences” such as brain swelling and brain bleeds.
Results showed that 17.3 percent of patients who received the drug suffered brain bleeding, as compared to 9 percent for those who were given a placebo.
Brain swelling was reported by 12.6 percent of people who took the drug, compared to 1.7 percent in the placebo group.
In both arms of the trial, deaths were reported at the same rate. The drug was developed by Biogen and Eisai.
Researchers and campaigners for patients affected by the disease including Bart De Strooper (director of the UK Dementia Research Institute) were pleased with the results.
He said, “This drug is the first to offer a real treatment option to people with Alzheimer’s.”
Although the clinical benefits of the drug appear limited, it is possible to expect that they will be more evident if they are administered for a longer period.
Need for longer trials
In Alzheimer’s disease, two key proteins – tau and amyloid beta – build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
Lecanemab targets amyloid. De Strooper stated that the drug was effective in clearing it, but also had “beneficial effect on other hallmarks” of Alzheimer’s disease, such as tau.
Nearly 1,800 people participated in the phase 3 trial. They were divided into two groups: those who received the drug and those who were given a placebo. The trial lasted for 18 months.
They were tested on a scale used for Alzheimer’s patients. It measures cognition, function, and for changes in amyloid and other indicators.
Tara Spires Jones, the UK Dementia Research Institute’s program leader, stated that there is no accepted definition of clinically significant effects in the cognitive tests they used.
“It isn’t clear yet if the modest decrease in decline will make much difference to those living with dementia. She said that it will take longer trials to prove the benefits outweigh any risks.
This drug is only effective for those with amyloid buildup at an early stage of the disease. It limits the potential use of the drug to these individuals.
Some experts believe that early diagnosis of Alzheimer’s disease is important to increase the number of people who can benefit.
“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,” said Richard Oakley, associate director of research at the Alzheimer’s Society.
He said that lecanemab’s safety was crucial. Although side effects were reported, the results will be examined carefully when the decision is made whether to approve the drug.
Biogen and Eisai brought Aduhelm, an Alzheimer’s medication, to market before there was much controversy. Its approval led to three resignations at the US Food and Drug Administration.
