The US Food and Drug Administration (FDA) approved the drug, which offers a new treatment for Alzheimer’s disease for the first time in 20 years, but there are also scientists who think the drug is ineffective.
The drug ‘Aducanumab’ tries to treat the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms.
But scientists are divided over the possible impact of the treatment, given the uncertainty in the results of scientific experiments.
The FDA explained that there is “significant evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is likely to enumerate significant benefits for patients.”
In March 2019, international trials of aducanumab involving nearly 3,000 patients were halted when it showed that the once-monthly drug was no better than a dummy drug at slowing the deterioration of memory and thinking problems.
But over the next few months, US manufacturer Biogen analyzed more data and concluded that the drug works when given at higher doses. The company also said that the drug significantly slows cognitive decline.
Aducanumab targets amyloid, a protein that forms abnormal clumps in the brains of Alzheimer’s patients that can damage cells and trigger dementia, leading to memory and thinking problems, communication problems, and confusion.
Aldo Ceresa, who was involved in the experiments, first noticed 10 years ago that he had problems distinguishing between left and right.
The 68-year-old doctor, who is from Scotland and currently lives close to his family in Oxfordshire, England, had to quit surgery after being diagnosed.
Ceresa took aducanumab for two years before the trials were stopped, and then had to wait almost as long until another trial started at the National Hospital for Neurology and Neurosurgery in London.
“I’m really, really enjoying this journey I’ve had – and frankly, I’m very, very grateful for the benefits it has provided,” Ceresa says, saying she is “quite happy to volunteer.”
Ceresa thinks the medicine helped her:
“I feel like I’m not so confused. It’s not as bad as it used to be. My confidence is coming back a bit.”
Ceresa says her family has noticed improvements as well.
“If I had to buy something in advance, I couldn’t remember where to find them in the kitchen. This problem has subsided.
“I’m not at the level I was before, but I’m moving in the right direction.”
It is estimated that more than 30 million people worldwide have Alzheimer’s disease, and most of these people are over the age of 65.
Analysis: Fergus Walsh, Medical Editor
We have to be realistic.
It’s neither a miracle drug, nor a cure for Alzheimer’s, but it’s the first treatment to address the destructive mechanism that leads to the destruction of neurons in the brain.
This makes it a turning point.
But scientific opinion is divided both here (in the UK) and in the US. While some welcome the approval, describing it as a turning point for the millions of people living with Alzheimer’s, others believe the drug will have only minimal benefits.
Director of the UK Dementia Research Institute Prof. Bart De Strooper says the decision to approve aducanumab is a “very important milestone” in the search for a cure for Alzheimer’s disease.
Over the past decade, more than 100 potential Alzheimer’s drugs have failed.
But Prof. Bart De Strooper hopes this will be a turning point for millions of people, adding that “there are still many hurdles to overcome.”
“We have to be clear that this is a drug that, at best, has little benefit and will only help very carefully selected patients,” says John Hardy, professor of neuroscience at University College London.
Robert Howard, professor of advanced psychiatry at University College London, described the drug’s approval as a “serious mistake” and warned that it could hinder treatment searches “for the next decade”.
Professor Howard said the US Food and Drug Administration ignored data from experiments that showed no slowdown in cognitive activity decline.
The UK-based ‘Alzheimer’s Society’, on the other hand, says the drug is “promising”, but notes that it is “just the beginning of the road to new treatments for Alzheimer’s disease.”
Another charity, Alzheimer’s Research UK, wrote a petition to British Health Secretary Matt Hancock, explaining that they wanted the government to give the drug quick approval.
“People with dementia and their families have been waiting for a very long time for new treatments that will change their lives,” said Hilary Evans, Chief Executive Officer.
While many doctors are skeptical of aducanumab’s benefits, US approval could allow more resources to be devoted to research on dementia, which is far less than on cancer or heart disease.