Everything we know about breakthrough Alzheimer’s drug Donanemab

A new Alzheimer's drug is being hailed as a "turning point" in the fight against the disease, with researchers saying it marks the beginning of a "new era where Alzheimer's could become treatable".

Alzheimer’s disease is the most common cause of dementia in the UK and affects memory, thinking and other mental abilities. It is a progressive condition which means symptoms develop gradually over time and eventually become more severe.

In a study published on Monday, scientists revealed new drug Donanemab has been found to slow the progression of the disease.

They said Donanemab slows “clinical decline” by up to 35 per cent, meaning that people with the disease could still go about performing day-to-day tasks including shopping, housekeeping, managing finances and taking medication.

It comes after the results from Lecanemab, the first drug to be hailed as a breakthrough for Alzheimer’s, were published last year. Researchers found that after 18 months, the drug slowed disease progression by 27 per cent compared with patients taking a placebo.

Here we take a look at everything we know about the groundbreaking new drug Donanemab:

Donanemab is a monoclonal antibody that binds to a protein that builds up in the brain during the early stages of Alzheimer’s.

According to Alzheimer’s Society, the drug is a disease-modifying treatment which means that it could tackle the root causes of Alzheimer’s rather than just relieve its symptoms.

Eli Lilly, the pharmaceutical company that manufactured the drug, reported it slows cognitive decline by 35.1 per cent following trial results published today.

In response, Alzheimer’s Research UK said that “we’re entering a new era where Alzheimer’s disease could become treatable”. And the Alzheimer’s Society said that treatments like Donanemab could one day mean that Alzheimer’s could be likened to other long-term conditions such as asthma or diabetes.

During the trial, researchers examined almost 1,734 people with early-stage Alzheimer’s.

They were given a monthly infusion of Donanemab until the distinctive plaques in the brain were gone.

The study, published in the Journal of the American Medical Association, concluded that after 76 weeks of treatment, Donanemab was able to slow clinical decline by 35.1% in people with early Alzheimer’s whose brain scans showed low or medium levels of a protein called tau.

When the results were combined for people who had different levels of this protein, there was a 22.3% slowing in disease progression.

Researchers found that among a small number of people in the study, there were some serious side effects such as brain swelling.

Three volunteers who were in the drug-controlled group and one in the placebo group died. Their deaths were considered “treatment related”.

The company said it is ready to work with health regulators in the UK as well as the NHS and government on the “appropriate regulatory next steps”.

Hilary Evans, who is also chief executive of Alzheimer’s Research UK, said that if a licensed treatment became available in the next year, it would only be available to “small pockets in the UK”.

Though the cost of Donanemab is not yet known, Lecanemab costs more than £21,000 per person per year.

“Maybe some of the big university hospitals that have the research infrastructure, scanners and equipment would be in a good place to deliver it,” she told The Observer.

“If you aren’t a patient who maybe lived in the vicinity of one of those hospitals, then you wouldn’t be receiving it. So there would be a massive postcode lottery and people vying to pay privately for these drugs.”

A spokesperson for the National Institute for Health and Care Excellence (Nice), said: “Nice has already started work on its appraisal of Donanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease.

“Our aim is to produce recommendations on its use in the NHS as close as possible to it receiving its UK licence. To do this we are already talking to the NHS and the company.

“Whether a medicine is recommended by Nice is influenced by many factors including the evidence on how well it works but importantly also by its price, which is set by the company.

“It will also be important during our evaluation of Donanemab to understand the services required by the NHS to deliver it and how those eligible for treatment will be identified.”

Dr Susan Kohlhaas, executive director of research and partnerships at Alzheimer’s Research UK, said: “Today’s announcement marks another milestone.

“Thanks to decades of research, the outlook for dementia and its impact on people and society is finally changing, and we’re entering a new era where Alzheimer’s disease could become treatable.”

Dr Kohlhaas stressed that regulators need to “balance” the benefits and side effects of the drug “before it is given a license for use”.

Sir John Hardy, professor of neuroscience and group leader at the UK Dementia Research Institute, UCL, added: “The successful outcome of the Eli Lilly’s anti-amyloid antibody Donanemab is great news for Alzheimer’s disease and confirms the positive and similar outcome for Eisai’s Lecanemab trial late last year.

“The results are very similar, and that in itself is reassuring.

“Disease progression is slowed about 30 per cent, but it too has occasionally serious complications which require monitoring.

“Scientists now need to work to understand what we need to do to stop the disease rather than just slow it, but the major immediate task will be to organise NHS Alzheimer provision to be able to use these therapies.”