Tens of thousands of dementia patients will be enrolled in clinical trials designed to dramatically speed up the search for a cure, leading scientists have announced, as a second treatment is rejected for use on the NHS.
Dementia presents a rapidly growing threat to health and social care services, with increasing numbers of people affected. But despite the urgent need for cheap and effective drugs to treat the condition, only 61 patients took part in UK trials in 2021-2022.
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 in trials.
The UK Dementia Research Institute (UK DRI), which is co-leading the scheme Health Data Research UK (HDR UK), has said it will recruit tens of thousands of dementia patients to help speed up the discovery of new treatments for the disease.
The launch comes a day after a new Alzheimer’s drug has been rejected for use on the NHS in England after 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 by the Medicines and Healthcare Products Regulatory Agency (MHRA) on Wednesday, 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 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 that the UK is no longer a good place to start new dementia treatments”.
However, experts involved in the new Dementia Trials Accelerator rejected this claim.
Prof Siddharthan Chandran, director of the UK DRI, said: “The Dementia Trials Accelerator’s aim is to position the UK as the preferred destination for pharmaceuticals and industry to invest in and conduct late-stage clinical trials.
“The UK has all the assets to be a dementia powerhouse, from world-class science, cohorts and data infrastructure to a unitary healthcare system.
“The accelerator will bring these assets together to ensure that people at high risk or living with dementia have every opportunity to participate in clinical trials.”
Jennifer Brown, 74, a patient participating in a clinical trial for Alzheimer’s, said she welcomes more opportunities for people to participate.
“Hopefully, our contribution and that of others in such trials will hasten an understanding, and eventual eradication, of this terrible disease.”
Science Minister Patrick Vallance said dementia was a “horribly cruel” condition, but breakthroughs offered hope it could soon become treatable.
Donanemab and lecanemab were considered a major step forward in research because they targeted a known cause of the disease, rather than just treating the symptoms.
However, neither remedy was a cure. Patients who take them do not get better, but the drugs slow the progression of the disease. Both also come with large costs, including the price of the drugs and monitoring for significant side effects including brain swelling and brain bleeding.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said it was incredibly disappointing that NHS patients would not have access to either drug.
“While these drugs are not a cure and carry the risk of side effects, trials show that they are the first treatments to slow the decline in memory and thinking skills associated with Alzheimer’s, rather than just relieving symptoms.”
However, Prof B Paul Morgan, from the UK’s Dementia Research Institute Cardiff, said the Nice decision was “understandable” as the drugs were “significantly expensive, difficult to administer and potentially harmful”.
Chandran said the drugs were “just the opening chapter for Alzheimer’s treatments” and he was confident the UK was at an “important moment” on the road to developing better, safer treatments.
