A so-called ‘wonder’ drug for Alzheimer’s may cause life-threatening brain bleeds in a third of patients who take it, a new study has revealed.
The breakthrough medication has previously been hailed ‘a new hope’ for patients due to its ability to slow the memory-robbing illness in its early stages by almost 35 per cent.
But some experts have long warned that side effects of the drug — called donanemab — massively outweigh its benefits.
Now, a new study from the company that produces the medication itself has confirmed the findings of early studies that flagged donanemab’s deadly risks.
Scientists working for pharmaceutical firm Eli Lilly found that, in 3,000 patients given the drug over the course of three years, the monthly jab more than doubled the risk of a deadly condition that can trigger dangerous bleeds and swelling.
Known as amyloid-related imaging abnormalities, or ARIA, this occurs when the medication causes an inflammation of the blood vessels in the brain.
While it usually has no symptoms and often goes away on its own, it can cause brain swelling, bleeding, as well as headaches and confusion.
As a result of this, 31 per cent of those studied were discovered to have brain bleeds while on the drug.
Donanemab has been proven to slow progression of the disease by as much as 35 per cent in trials by helping to remove the build up of the harmful protein amyloid in the brains of people with early-stage Alzheimer’s
Experts have long believed donanemab could herald a new era of dementia treatment, after studies showed it slowed the memory-robbing illness in its early stages
This was compared to just 1.9 per cent of those taking the placebo.
Meanwhile, one in four suffered brain swelling. Nearly six per cent had symptoms of this, which can range from anything from confusion to dizziness and nausea.
The researchers noted that 79 patients had to stop taking the medication as a result of the severe side effects.
The scientists used data from more than 3,000 patients with early Alzheimer’s disease aged 60 to 85, who were given the drug over two separate three-year trials, to obtain their results.
For the patients with the most serious ARIA cases, symptoms occurred within the first three months of taking the drug.
Pharmaceutical companies are required to disclose all clinical trial results — including negative findings — within a year of the trial’s end date.
‘While ARIA-E events were typically transient and asymptomatic, ARIA can be serious, life threatening, or fatal,’ wrote lead researchers Dr John Sims and Dr Jennifer Zimmer, Eli Lilly’s senior medical director and associate vice president, respectively.
‘Therefore, safety monitoring is necessary with donanemab.’
The medication, which patients receive through a drip in their arm every month, works by stimulating the body’s immune system to remove the build up of the harmful protein amyloid in the brains of people with early-stage Alzheimer’s.
In October, it got the green light from UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
But NHS health chiefs NICE decided to block it — along with a second, similar Alzheimer’s drug called lecanemab, as both produced benefits ‘too small’ to justify the cost to the health service.
Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss
However, private clinics in London have already begun to offer the jab for eye-watering sums.
London clinic Re:Cognition Health has priced the drug at £60,000 per year, and administered their first dose of donanemab in January of this year.
More than 700,000 people in the UK currently suffer from Alzheimer’s disease.
Recent analysis by the Alzheimer’s Society estimates the overall annual cost of the dementia to the UK is £42billion a year, with families bearing the brunt.
An ageing population means these costs – which include lost earnings of unpaid carers – are set to soar to £90billion in the next 15 years.
Around 944,000 in the UK are thought to be living with dementia, while the figure is thought to be around 7million in the US.
Alzheimer’s affects around six in 10 people with dementia.
It is thought to be caused by a build-up of amyloid and tau in the brain, which clump together and from plaques and tangles that make it harder for the brain to work properly.
Eventually, the brain struggles to cope with this damage and dementia symptoms develop.
Memory problems, thinking and reasoning difficulties and language problems are common early symptoms of the condition, which then worsen over time.
Alzheimer’s Research UK analysis found 74,261 people died from dementia in 2022 compared with 69,178 a year earlier, making it the country’s biggest killer.
