Poor Delivery Of Dementia Trials Could Leave UK Trailing Behind Says Alzheimer’s Research UK

The UK risks losing ground to other countries in the search for new dementia treatments if it does not make significant changes to the way it runs clinical trials, according a new report from Alzheimer’s Research UK. The analysis highlights a worrying lack of people with dementia taking part in clinical research, as well as a lack of diagnostic capacity needed to recruit people into these studies.

In the report – Translating Science into breakthroughs: the future of late-stage dementia clinical trials in the UK – published today (20 May 2021), the UK’s leading dementia research charity said urgent reform is needed if the country is to play a leading role in developing new treatments and transforming the lives of people with dementia.

People with dementia have been among the hardest hit by the pandemic, with a quarter of those dying from COVID-19 in the UK also having had dementia. With no new treatments for dementia in nearly two decades, the charity argues that the rapid development of COVID-19 vaccines offers an example of what could be achieved for dementia, with the right funding and priority from government.

According to the report, clinical research into dementia must be embedded in all parts of the NHS in order to increase participation numbers and improve the likelihood of successful trials.

Clinical trials offer early access to potential treatments for people enrolled in them, as well as benefitting UK life sciences, but the report reveals that the UK is losing ground to other countries. This is particularly true for crucial phase III trials that involve larger numbers of participants and are an essential element of developing new treatments for those with dementia.

When compared with the five largest economies in the EU – Germany, France, Spain, the Netherlands and Italy – the UK came third behind Germany and Spain in hosting phase III clinical trials. In this phase, every country apart from the Netherlands performs better when compared with the UK.

The gap between the number of dementia clinical trials hosted in the US and UK has widened. In 2016 the US hosted 23 more trials than the UK but this had grown to 42 more in 2020.

• A fragmented healthcare system leading to suboptimal links between clinical research and dementia diagnoses in the NHS, resulting in lack of awareness of opportunities to take part in research initiatives.
• Only a small number of people eligible to take part in dementia clinical trials actually do so – just 2% of those diagnosed with dementia are part of Join Dementia Research (JDR), the organisation which matches people to dementia research in the UK.
• A lengthy and bureaucratic process in the recruitment and approval of clinical trials. It can take about three years to recruit enough dementia patients to run an 18-month trial. The average cancer trial takes 2.3 years from study start up to completion of the trial.
• The risk of dementia researchers leaving the field due to lack of funding. The government has yet to deliver on its 2019 manifesto promise to double dementia research funding to £160 million a year.
• Failure to diagnose more people at an early stage – when they are more likely to be eligible to take part in clinical trials – due to limited access to and cost of diagnostics.

The report makes a series of recommendations to address these issues and transform the dementia clinical trials landscape, to build on the UK’s reputation as a hub for research and development in life sciences.

In the report, Alzheimer’s Research UK says the country can play a leading role in the development of new treatments by increasing research funding to enable more accurate and timely diagnoses, streamlining the clinical trial process and improving opportunities for people with dementia to take part in studies by embedding clinical research into all parts of the NHS.

It points to the rapid approval and rollout of COVID-19 vaccines as reason to believe that future treatments of conditions such as dementia could be developed and approved much faster. The report argues that the UK should use this experience to set up a network of high performing Alzheimer’s disease clinical trial sites to reduce bureaucracy and speed up regulatory approval, and in doing so make the country a more attractive location for pharmaceutical companies to run clinical trials.

Susan Kohlhaas, Director of Research, Alzheimer’s Research UK, said:

“Improving dementia clinical trials should be a top priority for policymakers, with investment in research and a fundamental shift to embed clinical research into conventional healthcare.

“It’s vitally important that the government’s next Dementia Strategy includes a plan for improving clinical research and making access to diagnostic tools more widely available.

“Researchers and scientists have risen to the challenge presented by a global pandemic and their efforts have shown it is possible to make significant breakthroughs when tackling a health emergency. Now we must give them the tools and resources needed to do the same for dementia.”

Hilary Evans, Chief Executive of Alzheimer’s Research UK, added:

“With a healthy industry pipeline of potential dementia treatments, it is more important than ever that this country is an attractive place to host late-stage clinical trials. The government needs to be ambitious about the role the UK can play and act now to ensure we are a centre of global excellence for dementia clinical research.

“It has been nearly two decades since the last treatment for dementia, so people have been waiting long enough for a significant breakthrough. It is hugely concerning that people in the UK with dementia could be missing out on vital treatments due to the way clinical trials operate in this country.

“Dementia is one of the biggest health care challenges we face. As part of the post-pandemic recovery, it is vital the approaches used in approving and deploying vaccines against COVID-19 can be used to help find a new treatment and improve the lives of people with dementia.”