Alzheimer's trials seeks tens of thousands of volunteers after landmark drug rejected

A landmark drug has been rejected by NICE after researchers showed just 61 UK patients took part in medical trials to prove its effectiveness.

Now scientists have promised a mass expansion in research and want to recruit tens of thousands of people to be part of trials of the landmark drug donanemab. The setback has been branded as "frustrating" for those with the disease by charities, which described the decision as “incredibly disappointing”.

The has confirmed it will not fund donanemab - the most effective drug yet to slow the progress of Alzheimer’s disease - as it was licensed by safety regulators. In the US, the drug is estimated to cost around £25,000 per patient each year, but equals around £60,000 once monitoring and scans, are included.

It is estimated that around 70,000 adults in England would have been eligible for treatment with donanemab. NICE said the costs could not justify the benefits, estimating that the monthly injections slowed cognitive decline by around four to seven months.

Alzheimer’s Research UK's chief executive Hilary Evans-Newton, has urged the health secretary Wes Streeting to “break the deadlock we’re facing, where research is delivering new treatments but they remain out of reach for patients”.

The UK Dementia Research Institute today said it was launching a £20million initiative to boost the numbers receiving medicines through trials. The Dementia Trials Accelerator, funded by the Medical Research Council, will allow “tens of thousands” to take part. The Institute said one of the key challenges is getting large enough numbers of volunteers to come forward and ensure enough get through screening procedures.

NICE director of medicines evaluation, Helen Knight, said: “For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money. Our independent committee looked at all the available evidence, including the benefits for carers.

"This shows donanemab could slow down cognitive decline by 4-7 months, but this is just not enough benefit to justify the additional cost to the NHS. The cost-effectiveness estimate for donanemab is 5 to 6 times above what Nice normally considers an acceptable use of NHS resources. I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed.

A Department of Health and Social Care spokesman said: “These are very difficult decisions to make and it is right that they are taken independently, based on an assessment of the available evidence on the relative costs and benefits of a treatment. The Government is committed to continuing to expand research and innovation in this area, and will continue to work with NHSE and NICE to make treatments available as and when they are assessed to be ready.”