The rate of decline in memory and thinking in people with early Alzheimer's disease has been slowed by an experimental drug.
After 18 months, the cognitive decline of Alzheimer's patients given the drug was more pronounced than that of placebo patients. It is the first time a drug has been shown to change the trajectory of a disease.
The director of research at Alzheimer's Research UK said that this is the first phase 3 trial of an Alzheimer's drug in a generation. Alzheimer's is an inevitable part of old age. If you intervene early, you can make a difference.
Patients in the study were given lecanemab twice a week. It was shown to reduce toxic plaques in the brain.
About a fifth of patients experienced side-effects, including brain swelling or brain bleeding, which can be seen on PET scans.
The results show that sticky plaques in the brains of people with dementia can cause cognitive decline.
Some questioned whether the research field had been on the wrong track after a series of previous drug candidates were shown to reduce levels of amyloid in the brain.
Rob Howard, a professor of old age psychiatry at University College London, said: "This is an unambiguous statistically positive result and represents something of an historic moment when we see the first convincing modification of Alzheimer's disease." We've waited a long time for this.
Regulators in the US and Europe are expected to approve the drugs by the end of the year. It will be difficult for healthcare providers to fund the drug if it is approved because the clinical improvements seen by patients fall just below a benchmark.
Patients on the drug scored higher on a 14-point scale used to assess Alzheimer's progression, with an Alzheimer's patient being expected to decline by 1 point a year.
There are going to be some very difficult conversations and decisions in the next few months.
The benefits of the drug will be dependent on whether patients maintain a better trajectory beyond the first 18 months.
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The drug could decline at an earlier stage. People with a high risk of Alzheimer's who have not yet developed symptoms are being recruited to participate in further trials.
One in 14 people over the age of 65 are affected by Alzheimer's in the UK, and the prospect of an effective therapy will focus attention on the ability of healthcare services to deliver treatment.
According to Alzheimer's Research UK, only one in three psychiatry services would be ready to deliver a new treatment within a year and, in the UK, many patients are diagnosed at a much later stage than those who participated in the latest trial.
Prof Jon Schott is the chief medical officer of Alzheimer's Research UK and a professor of neurology at the University College London.
The demand will be very high if this is licensed and approved by Nice. We need to address that now because we are not prepared to deliver at scale.
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