LAST UPDATE | 17 Jul 2023

A NEW DRUG has been hailed as a “turning point in the fight against Alzheimer’s” after it was found to slow the progression of the disease.

Donanemab was found to slow “clinical decline” by up to 35%, meaning that people with disease could still go about performing day-to-day tasks including shopping, housekeeping, managing finances and taking medication.

The health spending watchdog in England is already assessing whether the drug can be used in the NHS. In Europe, decisions on drug approval are made by the European Medicines Agency (EMA).

Commenting on the news today, Dr Laura O’Philbin, Research and Policy Manager with the Alzheimer’s Society of Ireland, said the data was “incredibly heartening”.

“The data published this afternoon indicates that Donanemab is another credible treatment option that can alter the course of Alzheimer’s Disease and slow its progression,” she said.

“This is a further scientific leap in the development of treatment options for Alzheimer’s Disease, and that is incredibly heartening.

We have entered a new era of drug development, particularly as this news comes just two weeks after the FDA granted full approval to the Lecanemab drug in the United States.

Lecanemab was found to reduce memory decline among patients with early-stage disease. The drug is currently being assessed by the EMA before it can be approved.

While there are no guarantees, we are hopeful that if approved by regulators, disease-modifying therapies will reach Ireland in the next couple of years,” Dr O’Philbin said.

“Should this happen, significant work is required to ensure our health system is ready to deliver it, and that work must start now.

“It would be devastating if we had a safe and effective treatment that our health system could not deliver.

The Alzheimer Society of Ireland looks forward to working with the Government, political representatives, clinicians, people with dementia and family carers on this matter. 

Alzheimer’s Research UK said that “we’re entering a new era where Alzheimer’s disease could become treatable”.

The UK’s 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.

The charity said that new treatments including donanemab – which works by removing a protein called amyloid that builds up in the brains of people with Alzheimer’s – heralds a “new era” for Alzheimer’s disease.

The research

It comes as scientists published the final results of the trial – known as TRAILBLAZER ALZ-2 – examining the safety and efficacy of the drug, manufactured by Eli Lilly and Company.

Researchers examined almost 1,800 people with early-stage Alzheimer’s.

Half of them received a monthly infusion of donanemab and the other half were given a dummy drug, also known as a placebo, over 18 months.

The study, published in the Journal of the American Medical Association and presented to the Alzheimer’s Association International Conference in Amsterdam, 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.

But researchers did find that among a small number of people in the study there were some serious side effects such as brain swelling.

Meanwhile three deaths in the donanemab group and one in the placebo group were considered “treatment related”.

Eli Lilly and Company said some people taking the drug would be able to finish the course of treatment in six months once their amyloid plaque cleared.

It said treatment with donanemab reduced amyloid plaque on average by 84% at 18 months, compared with a 1% decrease for participants on placebo.

Some 47% of people taking the drug who had early-stage disease and low or medium levels of tau were found to stall the disease for a year.

Dr Mark Mintun, group vice president of neuroscience research and development at Lilly and president of Avid Radiopharmaceuticals, said:

“People living with early, symptomatic Alzheimer’s disease are still working, enjoying trips, sharing quality time with family – they want to feel like themselves, for longer.

The results of this study reinforce the importance of diagnosing and treating disease sooner than we do today.

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”.

Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said:

If approved, we believe donanemab can provide clinically meaningful benefits for people with this disease and the possibility of completing their course of treatment as early as six months once their amyloid plaque is cleared.

The results come after another drug – lecanemab – was found to reduce memory decline among patients with early-stage disease.