Regulators in the US have approved the first new medication for Alzheimer's in nearly two decades.
Aducanumab is the first medication intended to slow cognitive decline in people in the early stages of Alzheimer's. It includes antibodies designed to attach to and remove amyloid plaques which are thought to cause the damage in the brain that leads to Alzheimer’s disease.
The Food and Drug administration conditionally approved the use of Aducanumab, which will go by the brand name Aduhelm.
"Its approval is based on the fact that the antibody definitely clears the amyloid plaques out of the brain. And then the assumption that that will benefit the patient in the long run," said Professor Christopher Rowe.
Rowe is the Director of the Australian Dementia Network at the University of Melbourne and he told Aged Care Insite that the trials of aducanumab are very promising, and this is part of a growing body of positive results in this area.
"In one of the three trials, they did say that there was a 30 per cent slowing in the rate of decline in memory and thinking and function of day-to-day activities. So, there's a good signal there," he said.
"What really makes me much more confident about it is the data that the FDA couldn't consider. There are three other companies who have got anti-amyloid antibody drugs.
"They all cleared the amyloid antibodies and they've all consistently shown this 30 per cent slowing of cognitive decline. So that's memory and thinking.
"Given there's other information out there in the wider world, it does look like it's a pretty consistent finding now that if you get the amyloid plaques out of the brain in people who have mild dementia, you slow their rate of decline."
Trial and error
The announcement on Monday comes as a surprise to some. As recently as 2019 aducanumab trials were paused as early results found it was not likely to benefit patients.
Further analysis brought the trials back to life, however the FDA approval is conditional on manufacturer Biogen conducting further clinical trials.
Some worry that as the drug has been approved, and will be available to Americans via a doctor's prescription, Biogen might struggle to get participants for a new trial.
Associate Professor Kathryn Goozee from KaRa Minds, who is running an Australian clinical trial of the drug, does not share that concern.
"I feel that we're cognisant of the effect of these results, whilst encouraging, it's early days. We need to keep gathering more data and more research, and there's other studies of a similar approach that are also running," she told Aged Care Insite.
"And I think it's not going to change current clinical practice within Australia. Maybe one of the good things that might come from this, is perhaps raising awareness of the importance of research and to get more volunteers to come forward for studies."
Hope and time
Rowe says that what this drug can offer people in the early stages of Alzheimer's is time.
"It just slows the rate of decline. And that should buy you a couple of years of a reasonable life."
He says that if you are diagnosed now you have approximately a 10-year life expectancy, the last years of which are often spent with severe dementia.
"If you can slow that 10-year period down by 30 per cent, you're gaining a couple of years before you get to the severe dementia phase stage for at least a year anyway; one to two years, I would say.
"It's just the beginning. It's a conditional approval. But it's a good start and it's stimulating excitement and further investments in research and development of treatments for Alzheimer's disease. So, I think it's a very good thing."
For Goozee, this drug has the potential to change lives.
"It offers hope."
The drug is currently under review by the Therapeutic Goods Administration (TGA) in Australia with an announcement expected early in 2022.
Someone in the world develops dementia every 3 seconds. There were over 50 million people worldwide living with dementia in 2020. This number is expected to almost double every 20 years, reaching 82 million in 2030 and 152 million in 2050.Do you have an idea for a story?
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