Dementia drugs research on 'cusp of a revolution' but could stall due to critical shortage of trial participants

Research into new dementia drugs is on the 'cusp of a revolution' but could stall because of a critical shortage of trial participants, a major report warns.

For the first time, the pipeline of innovative diagnostic tests and treatments for Alzheimer's disease and other dementias is rapidly expanding.

But this progress risks grinding to a halt unless more people take part in clinical trials and restrictive eligibility criteria are reviewed, Alzheimer's Disease International says.

The UK-based federation of 105 global Alzheimer's charities has today published a report that reveals more than 158 potential drugs are being evaluated across more than 192 trials worldwide.

These require an estimated 55,000 participants to keep them going.

However, stringent screening criteria lead to many willing volunteers being excluded before they are enrolled, meaning 350,000 people must actually come forward to fulfil recruitment needs.

The Alzheimer's Society annual conference this week heard the situation in the UK is particularly dire, with just 551 people on dementia trials here, compared with around 24,000 on cancer trials.

Chris Lynch, acting chief executive of ADI, said: 'This is a moment of real hope for dementia research.

Everyone experiences dementia differently. Use this checklist to help you make a note of your symptoms before you talk to your GP.

Progress risks grinding to a halt unless more people take part in clinical trials and restrictive eligibility criteria are reviewed, Alzheimer's Disease International says 

'After decades of frustration, clinical trials have shown for the first time that new treatments can slow the progression of Alzheimer's disease, and a burgeoning pipeline of treatment trials brings real hope.

'We are on the cusp of a revolution in dementia diagnostics and treatments, but major barriers to recruiting trial participants risk slowing progress.'

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Our Defeating Dementia campaign aims to raise awareness of the disease, in an effort to increase early diagnosis, boost research and improve care.

The new ADI report, titled 'A new era in dementia clinical trials', says barriers to clinical trial participation often begin long before someone reaches a research centre.

Delayed diagnosis, limited access to specialist testing, travel costs, language barriers and the potential need for a care partner to be present can all prevent people from being considered for a trial.

These challenges are further complicated when trying to recruit trial volunteers in the pre-symptomatic or at-risk stages of Alzheimer's and other dementias.

Even when someone is interested, their medical or treatment history may make them ineligible.

Mr Lynch added: 'It is essential that governments invest in early diagnosis, research infrastructure, and public trial readiness, but there also needs to be greater awareness among medical professionals, who can recommend trials to those living with dementia.

'Trial sponsors must also continue to innovate and build further diversity into research from the outset and reduce unnecessary demands on participants and care partners.

Professor Craig Ritchie, chief executive of Scottish Brain Sciences and a researcher included in the report, said the pace of progress marks a pivotal moment for brain health research 

'Remote assessments, local testing, mobile research services, and simpler requirements could make trials accessible to people currently excluded by cost, distance, or caring responsibilities.'

The report further warns that people may never hear about trials for which they could be eligible, due in part to limited awareness among healthcare professionals and the time pressures they face when discussing research opportunities.

Professor Craig Ritchie, chief executive of Scottish Brain Sciences and a researcher included in the report, said the pace of progress marks a pivotal moment for brain health research.

He added: 'For the first time, there is a growing pipeline of treatments and tests that have the potential to detect and then delay, slow, and perhaps even prevent Alzheimer's disease.

'The opportunity before us is extraordinary.

'Advances that once felt distant are now becoming reality, bringing hope to millions of people and families affected by a range of neurodegenerative diseases.

'Every person who takes part in research helps us learn faster, understand more, and bring the next generation of tests and treatments closer.

'Together, we have a genuine chance to change the future of brain health for generations to come.'

Michelle Dyson, chief executive of Alzheimer's Society, said: 'We know many people are keen to take part in research but are diagnosed too late and never given the opportunity, while others face practical barriers that make participation difficult.

'That's why Alzheimer's Society and the UK Dementia Trials Network established a team of Dementia Research Nurses, to help more people living with dementia access clinical trials.

'This includes people from diverse backgrounds, who are currently under-represented in dementia research.

'The science is flying – but unless diagnosis and access to trials improves, we won't see these breakthroughs reaching the people who need them most.'

A new class of dementia drugs have been shown to reverse the underlying cause of the disease and give users many more months of quality life but they are more effective when taken early, meaning prompt diagnosis is essential.

They have recently been approved for use in the UK but not on the NHS.

Researchers say new treatments in the pipeline could prove even more effective and better value for money, meaning they are more likely to be approved for use on the health service.

A Department of Health and Social Care spokesperson said: 'We want to make the UK a world-leader in dementia research, which is why we're boosting clinical trial participation to 2,000 people across the next five years.

'Everyone should have the same chance to participate in life-changing research, so we want trials to be available across the country.

'We now have 158 drugs for this condition being tested in clinical trials, compared to only 24 a decade ago, and we are supporting numerous studies through the National Institute for Health and Care Research to give us a better understanding of neurodegenerative diseases including dementia.

'If we can work in partnership with patients, carers, families, charities and patient support groups, other government funders and the life sciences industry, then together we can boost participation in clinical trials and make big strides towards preventing and treating dementia.'