The world is “on the cusp” of a new drug treatment for Alzheimer’s that could free millions from the fear and heartbreak dementia brings.
A “very exciting” antibody medication has been proven to slow the disease by more than a third in those patients who show early symptoms.
It is the second drug in less than a year that has been found to delay progression following decades of failed treatments – and heralds a new era in dementia care.
Dr Susan Kohlhaas, of Alzheimer’s Research UK, said: “This is incredibly encouraging and another hugely significant moment for dementia research.
“We’re now on the cusp of a first generation of treatments for Alzheimer’s disease, something that many thought impossible only a decade ago.
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“People should be really encouraged by this news, which is yet more proof that research can take us ever closer towards a cure.”
The drug donanemab, made by US pharma giant Lilly, stimulates the immune system to destroy toxic proteins in the brain that are believed to cause dementia. It is given by intravenous infusion once a month for up to 18 months.
Donanemab was used in a trial
of 1,182 people with early-stage Alzheimer’s and intermediate levels of tau protein. After a year, 47 percent of those on the drug had not seen the disease progress, compared with 29 percent of those taking a placebo.
Researchers calculated that after 18 months the drug had slowed patients’ decline by 35 percent on average. The reduction in their ability to perform common daily activities was 40 percent less than previously.
Some 552 people with more advanced symptoms and high tau levels, which are harder to treat, also joined the study. When they were included in the analysis, the drug slowed decline by 22 percent overall.
Dr Eric Reiman, executive director of the Banner Alzheimer’s Institute in the US, called the results “very exciting”. There were some side-effects including swelling of the brain.
Lilly said most of those were “mild to moderate” but three patients died. Some 31 percent of patients receiving donanemab experienced small brain bleeds, as did 14 percent of those in the placebo group.
Dr Kohlhaas, executive director of research at Alzheimer’s Research UK, said: “The treatment effect is modest, as is the case for many first-generation drugs, and there are risks of serious side effects that need to be fully scrutinised before donanemab can be marketed. However, this news underlines the urgency of preparing the NHS to make these treatments available should regulators deem them safe.”
Scientists are eager to see the full trial results, which will be given at the Alzheimer’s Association International Conference in Amsterdam in July. The success of donanemab follows good results for lecanemab: in September it became the first drug proven to slow Alzheimer’s, by around 27 percent.
Dr Richard Oakley, of Alzheimer’s Society, said: “We now have two potential new drugs in just 12 months – and for the first time, drugs that seem to slow the progression of the disease. This could be the beginning of the end of Alzheimer’s.”
Lilly said it would seek regulatory approval for donanemab across the world “as quickly as possible”.
If approved in the UK, it is likely to be costly and medicines assessors will determine how cost-effective it is. Experts urged the NHS to improve diagnosis systems so patients who will benefit can be identified easily.
Dr Charles Marshall, neurologist at Queen Mary University of London, said specialists would calculate “the risks and benefits” once full results are published: “This will inform decisions about whether donanemab should be routinely given.”
