Recently, the results of a new Alzheimer’s drug trial were published in the journal Nature. The drug, called aducanumab, has been hailed as the first of its kind to remove the build-up of amyloid protein in the brain believed to prevent brain cells communicating, leading to irreversible memory loss and cognitive decline.
Several other Alzheimer’s drugs have been designed to target the build-up of amyloid protein in the brain, but none have succeeded in clearing the protein and improving outcomes for patients in the final stages of previous clinical trials.
For this recent study, researchers recruited 165 participants who were given varying dosage levels of aducanumab over a year, as well as one group who received a placebo. The researchers found that the highest dose of aducanumab resulted in an almost complete clearance of the amyloid plaques.
Dr Alfred Sandrock, from the Massachusetts-based biotech company Biogen, which is hoping to bring the drug to market, said: “This is the best news that we have had in our 25 years and it brings new hope to patients with this disease”.
Crucially the researchers also found that after six months of the treatment, patients stopped deteriorating compared with those taking a placebo, suggesting that their dementia had been halted.
This is all great news and very encouraging, since researchers are still unable to reach consensus about the exact cause of Alzheimer’s disease, and despite more than 400 drug trials, no drug has yet been shown to combat the disease effectively.
Adding to that, the last Alzheimer’s drug licensed in the UK hit the market more than a decade ago. So, on the surface aducanumab looks like the long-awaited and much-needed Alzheimer’s breakthrough the mainstream has been waiting for.
However, there is one thing the researchers have kept their lips sealed about… and the media have also largely failed to report on it (or conveniently chose to ignore it): Almost half of the participants in the trial who were given the highest dosage of aducanumab experienced a condition called ARIA — characterised by leakage of fluid from the blood into the brain.
ARIA is categorised as either brain micro-haemorrhages or vasogenic oedemas and it is a recognised side effect of drugs targeting amyloid build-up. Researchers are unclear on what the impact of it can be on the brains of Alzheimer’s patients…. But if you ask me, it sounds potentially dangerous.
So, here’s where I get confused:
Aducanumab is designed to protect the brain from a condition that affects memory and thinking skills. In a small human trial this drug has shown some success. However, it also caused a side effect that can potentially damage brain function.
Yet, before establishing all the risks involved in using aducanumab, the drug maker is pushing forward with the continued clinical development of the drug, and recruitment into phase 3 trials involving greater numbers of participants has already begun.
I cannot help but wonder what is really at play here: Finding an effective and safe treatment for Alzheimer’s disease? Or warming up the great big marketing machine for the first Alzheimer’s drug to hit the market in a decade, ready to be promoted as the next blockbuster?
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Antibody clears Alzheimer’s protein from brain in clinical trial, published 31.08.216, alzheimersresearchuk.org
Alzheimer’s: New drug that halts mental decline is ‘best news for dementia in 25 years’, published online 01.09.16, telegraph.co.uk