UK launches scheme to boost dementia trial participation

A UK initiative to tackle the "historically low" numbers of people taking part in dementia clinical trials has been launched with £20 million ($26 million) in funding from the government.

The Dementia Trials Accelerator (DTA) – which will be spearheaded by the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) – aims to increase the number of people participating in dementia studies to "tens of thousands" from just 61 in 2021-22.

There are estimated to be almost a million people in the UK living with dementia, with total direct and indirect costs to society estimated to reach around £42 billion this year.

UK DRI Director, Professor Siddharthan Chandran, said that a key objective of the DTA is to "position the UK as the destination of choice for pharma and industry to invest in and run late-phase clinical trials," adding that the UK "has all the assets to be a trials powerhouse in dementia, from world-class science, cohorts, and data infrastructure to a unitary healthcare system."

Earlier this week, a study found that Europe as a whole has been losing out to other regions, and particularly China, in the proportion of new commercial clinical trial starts. The DTA will specifically address some of the obstacles to commercial trials highlighted in the O'Shaughnessy review, including streamlined processes for setup and participation in studies.

The announcement came on the same day that a second new therapy for Alzheimer's disease, Eli Lilly's anti-amyloid therapy Kisunla (donanemab), was turned down for use by the NHS because it was not deemed cost-effective. Eisai and Biogen's amyloid drug Leqembi (lecanemab) was also rejected earlier this year on similar grounds.

In both cases, the health technology assessment (HTA) agency NICE concluded that the benefits of the two drugs were too modest – and the costs of monitoring for potentially serious side effects too great – to justify their significant cost to the health service.

That leaves patients with the option of paying for the drugs out of pocket or trying to get access to new therapies as part of a clinical trial, which the UK DRI said could be a major benefit of the DTA.

"This will boost opportunities for these people to participate in research, offering them the chance to receive potentially life-changing new treatments as part of a clinical trial […] with promising new treatments on the horizon," it said in a statement.

Among the objectives of the Accelerator is the use of digitally enabled methodologies to deliver clinical trials at scale in community settings across the UK, which should help to boost access and recruitment rates.

74-year-old Jennifer Brown, who is currently participating in the NorAD clinical trial of extended-release guanfacine as an add-on to standard cholinesterase drugs for Alzheimer's, said trial participation is important.

"Hopefully, our contribution and that of others in such trials will speed up an understanding, and eventual eradication, of this terrible disease," she added.

The DTA is funded by the Medical Research Council (MRC) and supported by the government's Dame Barbara Windsor Dementia Goals programme.

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