News of the approval of the new Alzheimer’s drug has hit the headlines this week.

Lecanemab has been approved by the MHRA, the UK’s regulator, but has been rejected by NICE so it will not be available on the NHS.

Lecanemab is part of a new class of drugs that is emerging. It slows the progression of Alzheimer’s disease by targeting one of the root biological causes of the disease – amyloid beta protein. This is a toxic protein that builds up in the brains of people with early stages of Alzheimer’s. Drugs that target these biological causes are termed disease-modifying dementia treatments. 

These antibody-based drugs work by triggering the brain’s immune system to reduce levels of amyloid beta protein in the brain. Thanks to extensive clinical studies, there is now a growing body of evidence to show that early treatment with this class of drugs can clear amyloid plaques from the brain. The Join Dementia Research’s volunteer community has played a role in this research.

Aducanemab:

In 2021, aducanemab was the first drug of this type approved for use in the United States, giving hope to dementia sufferers and their families. Limited for use by people with mild dementia, it was the first commercially available treatment to remove amyloid from the brain. 

Several clinical trials looking at aducanemab’s effectiveness took place internationally. These trials included participants recruited in the UK through Join Dementia Research. 

While aducanemab does not improve memory or thinking, its development was considered an important step in the search for new treatments.

The drug was developed by US pharmaceutical company Biogen but earlier this year they announced that they would stop developing and marketing the drug.

Nonetheless, it paved the way for the more recent drug lecanemab.

Lecanemab:

Lecanemab, developed by Biogen with Japanese company Eisai, is an antibody-based treatment.

In 2022 the Clarity-AD phase 3 trial results showed lecanemab slowed decline in memory and thinking skills. The trial involved 1,795 people globally with early-stage Alzheimer’s disease and included Join Dementia Research volunteers who took part from the UK.

In the trial, the drug successfully reduced the amount of amyloid protein present in the brain and reduced decline in quality of life measures as well as memory and thinking.

Lecanemab is also given to patients intravenously. Some trial participants experienced reactions to the intravenous drip. Others were found to have swelling or microbleeds in the brain, which are side effects common to all this type of drug that require careful monitoring. In a small proportion of treated patients, these had serious consequences.

Availability in the UK

Lecanemab gained approval in the US as a treatment for early Alzheimer’s disease in 2023  but has not been approved in Europe. However, some experts also think its effect on the disease may not be beneficial when weighed up against the risk of brain swelling.

Lecanemab has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. But the drug has also been assessed by the National Institute of Health and Care Excellence (NICE), who decided that it would not be available on the NHS because “the benefits are too small to justify the cost to the NHS”, and there are also potentially serious side effects to consider.

Professor Paresh Malhotra, NIHR Research Delivery Network (RDN) National Speciality Lead for Dementias said:

“The development of new Alzheimer’s treatments is very exciting and a major step forward for the field. It is effective against the underlying biology of the disease – it removes beta amyloid – and has been shown to have clinical benefits. However, these are modest and it only works in early disease with potentially serious side effects. We still need further research to develop more effective and safer treatments for Alzheimer’s disease, and also for the other common causes of dementia.”

Take part in research

Trials of new drugs are becoming increasingly available on Join Dementia Research, but these are just part of the fight against dementia. Studies looking at diagnosis and care are also important. This is because we also need to find ways to help people get an earlier diagnosis or have better experiences of care. 

Check your account regularly to see which studies you match to and if you’re not yet part of our community, sign up today!