Tens of thousands of UK dementia patients to be enrolled in clinical trials

Tens of thousands of dementia patients are to be enrolled in clinical trials designed to dramatically speed up the hunt for a cure, leading scientists have announced, as a second treatment was rejected for use on the NHS.

Dementia presents a rapidly growing threat to health and social care services, with soaring numbers of people affected. But despite the urgent need for cheap and effective drugs to treat the condition, only 61 patients took part in trials in the UK in 2021-22.

Now researchers are launching the Dementia Trials Accelerator, a £20m initiative funded by the Medical Research Council (MRC) to tackle the “historically low” numbers enrolled into trials.

The UK Dementia Research Institute (UK DRI), which is spearheading the scheme along with Health Data Research UK (HDR UK), said it would recruit tens of thousands of dementia patients to help fast-track the discovery of new treatments for the disease.

The launch comes a day after a new Alzheimer’s drug was rejected for use on the NHS in England after the health spending watchdog, the National Institute for Health and Care Excellence (Nice), said it “does not currently demonstrate value for the NHS”.

Donanemab was licensed for use in the UK on Wednesday by the Medicines and Healthcare products Regulatory Agency (MHRA), but Nice said the drug was too expensive for too little benefit to be used on the NHS.

It was the second disease-modifying Alzheimer’s drug to be rejected by Nice in three months. In August, the MHRA gave the green light to lecanemab, making it the first drug of its kind to be licensed for use in the UK.

But just like in the case of donanemab, Nice quickly said the benefits of lecanemab were too small to justify the significant cost to the NHS.

Charities said the Nice decision on Wednesday was another “frustrating setback” for people with dementia and “also risks signalling that the UK is no longer a good place to launch new dementia treatments”.

However, experts involved with the new Dementia Trials Accelerator rejected that claim.

Prof Siddharthan Chandran, director of the UK DRI, said: “The Dementia Trials Accelerator’s goal is to position the UK as the destination of choice for pharma and industry to invest in and run late-phase clinical trials.

“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.

“The accelerator will bring together these assets to ensure that people at high risk or living with dementia have every opportunity to participate in clinical trials.”

Jennifer Brown, 74, a patient who is participating in a clinical trial for Alzheimer’s, said she welcomed more opportunities for people to take part.

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

The science minister, Patrick Vallance, said dementia was a “dreadfully cruel” condition, but breakthroughs offered hope it could soon become treatable.

Donanemab and lecanemab had been billed as a huge step forward in research because they targeted a known cause of the disease, rather than just treating the symptoms.

However, neither of the drugs are cures. Patients who take them do not get better but the drugs slow the progression of the disease. Both also come with huge costs, including the price of the drugs and monitoring for significant side-effects including brain swelling and brain bleeds.

Hilary Evans-Newton, the chief executive at Alzheimer’s Research UK, said it was incredibly disappointing that NHS patients would not have access to either drug.

“While these drugs are not cures and come with risk of side-effects, trials show they are the first treatments to slow the decline in memory and thinking skills linked to Alzheimer’s, rather than just alleviating symptoms.”

However, Prof B Paul Morgan, of the UK Dementia Research Institute Cardiff, said the Nice decision was “understandable” given that the drugs were “eye-wateringly expensive, difficult to administer and potentially harmful”.

Chandran said the drugs were “just the opening chapter for Alzheimer’s treatments” and he was confident that the UK was at a “pivotal moment” in the road to developing better, safer treatments.