The new drug that ‘interrupts’ Alzheimer’s evolution – 07/17/2023 – Health

The results released on Monday (17) confirm that the drug donanemab, hailed as a turning point in the fight against Alzheimer’s disease, slows cognitive decline by about a third.

Mike Colley, 80, is one of dozens of volunteers in the United Kingdom to participate in the global study on this drug, whose details were published in The Journal of the American Medical Association (JAMA).

Every month, he receives an intravenous infusion at a clinic located in London and considers himself “a lucky person”.

From what is known so far, treatment with monoclonal antibodies can help in the early stages of the disease.

This type of therapy is evaluated against Alzheimer’s disease, but it is not used to combat other types of disease that affect memory and reasoning, such as vascular dementia.

That’s because these drugs are designed to deal with one of the hallmarks of Alzheimer’s disease — the buildup of a substance called beta-amyloid in the spaces between brain cells.

Mike and his family noticed some problems with memory and decision-making not long before the start of clinical trials with the drug donanemab.

Mike’s son Mark said it was very difficult to see the progression of symptoms at first.

“It was tough watching him struggle to process information and solve problems. But I think cognitive decline is hitting a plateau now,” he says.

In an interview with the BBC, Mike added: “I feel more confident every day.”

Donanemab, developed by pharmaceutical company Eli Lilly, works in the same way as lecanemab —tested by Eisai and Biogen laboratories — which made headlines around the world recently, when studies came out proving that this drug helps to delay the disease.

Although extremely promising, these drugs do not represent a cure for Alzheimer’s. The treatments are not without risks either.

Brain swelling was a common side effect in up to one-third of volunteers enrolled in the study evaluating donanemab. In most cases, this was resolved without causing major inconvenience.

However, two participants — and possibly a third — died from gray matter swelling.

What is dementia and how to treat it?

In the donanemab study, researchers looked at 1,736 people who were between the ages of 60 and 85 and diagnosed with early-stage Alzheimer’s.

Half of the group received a monthly infusion of the new treatment, while the other portion took a placebo, a substance with no therapeutic effect. The experiment lasted 18 months.

The main findings of the research were:

• Donanemab appears to have a significant benefit, at least for some patients
• Those who had early-onset disease and less amyloid buildup in the brain had the greatest benefit.
• Those who received the drug also maintained more daily activities, such as discussing recent news, answering the phone or engaging in routine activities.
• Alzheimer’s progression, as measured by what people can still accomplish in everyday life, was reduced by about 20 to 30% overall — and by 30 to 40% in a set of patients who researchers thought were most likely to have it. get a positive response;
• Significant side effects have been observed and patients need to be aware of the risks of treatment;
• Half of the patients who used donanemab were able to stop the treatment after one year because it had cleared enough beta-amyloid deposits.

Amyloid beta is just one part of the complex picture that makes up Alzheimer’s disease, and it’s unclear whether the treatment will continue to work for a longer period, experts warn.

Donanemab’s effects may be modest, but the results provide further confirmation that removing beta-amyloid from the brain can change the course of Alzheimer’s and help those affected by this devastating disease if timely treated, they say. .

Professor Giles Hardingham, from the Dementia Research Institute UK, said: “It’s fantastic to see these results published in full today. We’ve waited a long time for new treatments for Alzheimer’s so it’s really encouraging to see this progress. of an exciting and meaningful change in the care landscape for people affected by – or at risk of – dementia”.

Dr Susan Kohlhaas of Alzheimer’s Research UK said: “Today’s announcement marks a milestone. Thanks to decades of research, the outlook for treating dementia and the impact of the disease on people and society is finally changing. into a new era where Alzheimer’s can become treatable.”

Mike Colley turned 80 in April this year. At the birthday party, he surprised his family by singing my way for about 40 guests.

He told BBC News: “That’s the confidence I have now. I would never have done this 12 months ago.”

Son Mark added: “I never thought I would see my dad so full of life again. It was an incredible moment.”

Neuroradiologist Emer MacSweeney, medical director of the Re:Cognition Health clinic, led the trials of donanemab in the UK.

She stated that the results are significant and signal progress.

The UK’s Alzheimer’s Society called the newly published study a “turning point in the fight against the disease”,

“Science is proving that it is possible to delay Alzheimer’s,” said spokespersons for the entity.

These medications are not yet approved in Brazil by the National Health Surveillance Agency (Anvisa).

Lecanemab costs about US$ 27,500 (R$ 132,000) in the United States, where it is approved by regulatory agencies.

It is not yet clear what the price of donanemab is and how long it may take for it to gain approval.

But Alzheimer’s experts understand that having two drugs on the market would help promote competition and have the potential to drive down the prices of those treatments.