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Alzheimer’s breakthrough signals ‘beginning of the end’ in search for treatment

Alzheimers and dementia research, a brain scan in multi well tray used for research experiments in laboratory
It’s not just mini-brains that play video games (Credits: Getty Images/Cultura RF)

Experts have hailed the ‘beginning of the end’ in the search for effective Alzheimer’s treatments.

A new drug has been shown to reduce memory decline among patients with early stages of the disease.

Lecanemab, which is designed to target and clear amyloid – one of the proteins that builds up in the brains of people with Alzheimer’s – was found to slow decline in patients’ memory and thinking.

The phase three clinical trial results have been reported by Eisai, a Tokyo-based pharmaceutical company that has partnered with US biotech firm Biogen to develop lecanemab.

Eisai reported initial results in September from a trial on 1,795 participants with early Alzheimer’s disease.

Scientists found that after 18 months the drug slowed the disease progression by 27% compared with patients taking the placebo.

Full results from the study have since been published in The New England Journal of Medicine, with experts hailing it as long-awaited proof that Alzheimer’s disease can be treated.

‘This trial is an important first step, and I truly believe it represents the beginning of the end,’ said Professor John Hardy, group leader at the UK Dementia Research Institute at University College London.

‘The amyloid theory has been around for 30 years so this has been a long time coming. It’s fantastic to receive this confirmation that we’ve been on the right track all along, as these results convincingly demonstrate, for the first time, the link between removing amyloid and slowing the progress of Alzheimer’s disease.

‘The first step is the hardest, and we now know exactly what we need to do to develop effective drugs. It’s exciting to think that future work will build on this, and we will soon have life-changing treatments to tackle this disease.’

File photo dated 19/05/08 of a woman looking through a microscope, as a new study is the first to identify a molecule in urine that can reveal early-stage Alzheimer's disease. PA Photo. Issue date: Wednesday November 30, 2022. The research suggests the finding could pave the way for an inexpensive and convenient test for the disease. See PA story SCIENCE Alzheimers. Photo credit should read: David Davies/PA Wire
Alzheimer’s researchers have hailed the breakthrough as a massive step towards an effective treatment (Credits: PA)

Prof Bart De Strooper, director at the institute, added: ‘The overall conclusion is extremely positive. This trial proves that Alzheimer’s disease can be treated.’

Prof Nick Fox, director of the Dementia Research Centre, said: ‘I believe, it confirms a new era of disease modification for Alzheimer’s disease.

‘An era that comes after more that 20 years of hard work on anti-amyloid immunotherapies – by many many people – and many disappointments along the way.’

Dr Richard Oakley, associate director of research at Alzheimer’s Society, said the results had the potential to be ‘game-changing’.

‘They give us hope that in the future people with early Alzheimer’s disease could have more time with their loved ones,’ he said.

However, experts warned that UK officials have much to do to prepare to deliver the drug, provided it gets regulatory approval.

Changes needed in diagnostic services

There are two ways to tell whether there is amyloid on the brain – a brain scan or biomarker test which is currently done through lumbar puncture.

While a blood test is on the horizon, dementia services must rely on current tests which are expensive and can have big waiting lists.

Private patients and those living near to big dementia services can access these diagnostic tests, but the vast majority of the public cannot, experts said.

They warned that unless there are big changes in diagnostic services, people could become ineligible for lecanemab treatment while on the waiting list for diagnosis because it can only be given to patients with mild disease – if their disease progresses to a moderate stage while on the waiting list, they will no longer be eligible for treatment.

In Control Room Doctor and Radiologist Discuss Diagnosis while Watching Procedure and Monitors Showing Brain Scans Results, In the Background Patient Undergoes MRI or CT Scan Procedure.; Shutterstock ID 1243951690; purchase_order: -; job: -; client: -; other: -
Scans will tell if there’s amyloid in the brain (Credits: Shutterstock / Gorodenkoff)

Prof De Strooper said: ‘The participants of this trial were all people with very early-stage Alzheimer’s disease, which raises the question of how we ensure that people can access these drugs at the right stage in their disease course.

‘In parallel, we must focus on making early diagnosis easier and more accessible, so that treatments can be administered when they are most likely to have a positive impact, before amyloid levels are too high and start to cause damage to the brain.’

Experts also stressed that more work still needed to be done to investigate the drug’s side effects.

‘The trial results have shown us that there is a risk of side effects, including brain bleeds in a small number of cases,’ Prof Hardy said.

‘This doesn’t mean the drug can’t be administered, but that will be important to have rigorous safety monitoring in place for people receiving lecanemab, and further trials to fully understand and mitigate this risk.’

Molecules in urine could reveal the disease

Aside from the lecanemab treatment, a different study is the first to identify a molecule in urine that could reveal early-stage Alzheimer’s.

This research could pave the way for an inexpensive and convenient test for people to take.

In other words, it may be possible that a simple urine test to analyse formic acid – a sensitive urinary biomarker – could reveal if someone has early-stage Alzheimer’s disease.

The researchers tested 574 people who had Alzheimer’s disease of different levels of severity or healthy people, to identify differences in urinary biomarkers.

They found that urinary formic acid is a sensitive marker of subjective cognitive decline (self-reported experience of worsening or more frequent confusion or memory loss) that may indicate the very early stages of Alzheimer’s.

Researchers have identified a molecule in urine that could indicate Alzheimer's (Credit: Unsplash)
Researchers have identified a molecule in urine that could indicate Alzheimer’s (Credit: Unsplash)

Current methods of diagnosing the condition are expensive, inconvenient, and unsuitable for routine screening.

The study authors from Shanghai Jiao Tong University, and Institute of Biophysics, Chinese Academy of Sciences, said: ‘Alzheimer’s disease is a continuous and concealed chronic disease, meaning that it can develop and last for many years before obvious cognitive impairment emerges.

‘The early stages of the disease occur before the irreversible dementia stage, and this is the golden window for intervention and treatment.

‘Therefore, large-scale screening for early-stage Alzheimer’s disease is necessary for the elderly.’

The scientists analysed people’s urine and blood samples and performed psychological evaluations.

They found that urinary formic acid levels were significantly increased in all the Alzheimer’s groups compared with the healthy people, including the early-stage cognitive decline group, and correlated with a cognitive decline.

According to the researchers, this suggests formic acid could act as a sensitive biomarker for early-stage Alzheimer’s disease.

When formic acid levels were analysed in combination with blood tests, the study found what stage of the disease the patient was experiencing could be more accurately predicted.

The study authors say further research is needed to understand the link between Alzheimer’s and formic acid.

But writing in the Frontiers in Aging Neuroscience journal, they said: ‘Urinary formic acid showed an excellent sensitivity for early Alzheimer’s screening.

‘The detection of urine biomarkers of Alzheimer’s is convenient and cost-effective, and it should be performed during routine physical examinations of the elderly.’

Formic acid could act as a sensitive biomarker for early-stage Alzheimer's disease (Credit: Getty)
Formic acid could act as a sensitive biomarker for early-stage Alzheimer’s disease (Credit: Getty)

Sian Gregory, research information manager at Alzheimer’s Society, said: ‘This is an exciting discovery as it offers a potential new way of detecting Alzheimer’s disease, that is less invasive and more cost-effective than current methods of diagnosing the disease.

‘This has never been more important, with diagnosis rates for dementia at a five-year low.’

She added: ‘Research like this could give us new tools to revolutionise the way we detect Alzheimer’s disease to help target treatments to the right people at the right time.’

Dr Sara Imarisio, head of strategic initiatives at Alzheimer’s Research UK, said: ‘While a combination of blood and urine diagnostic markers could one day provide tests that help improve the accuracy of Alzheimer’s diagnoses for people across the UK, we still need further research to understand how formic acid in urine is linked to the disease.

‘We need to see larger studies that follow more people over longer time periods, which would help to evaluate whether formic acid in urine could be used as a biomarker for Alzheimer’s.’

MORE : Chris Hemsworth is taking acting hiatus after revealing increased risk of developing Alzheimer’s

MORE : Beer could hold the key to preventing Alzheimer’s, study suggests

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