Drugs with the potential to change the course of Alzheimer's disease are expected to be approved by mid-year in the UK. However, healthcare services may need to change to ensure that all patients have equitable access to these new modifying anti-amyloid therapies.
People in the UK with early-stage Alzheimer's disease may be suitable for the latest drugs which aim to halt progress of the condition but delivery of these new treatments will require a major restructure to existing dementia services, finds a new study co-led by UCL researchers.
The disease-modifying drugs, lecanemab and donanemab, slow cognitive decline in people with early-stage Alzheimer's disease. And they have been granted 'breakthrough therapy' status in the UK because of their ability to remove beta amyloid protein in the brain, build-up of which is thought to have a key role in the development of the disease.
Already licensed for the treatment of Alzheimer's disease in the US in 2023, regulatory approval of these drugs for use in the UK is expected shortly.
However, the new study, published in the Journal of Neurology Neurosurgery & Psychiatry, highlights how a raft of clinical staff and diagnostic and monitoring tests and scans will be required to maximise the effectiveness of the treatments.
As a result, UK healthcare services may need to change.
Alzheimer's disease is the most common cause of dementia. Of the 944,000 people living with dementia in the UK, 60-80% have Alzheimer's.
In the UK, dementia care is mostly centred around psychiatry-led memory clinics in the community. In their current state, it is extremely unlikely that disease modifying therapies will be administered in these settings.
Delivery of these new treatments will require a major restructure to existing dementia services - from determining eligibility to delivery of the treatment itself, including follow-up. It will require additional staff and training across imaging, diagnostics and pathology, and other clinical services. It will also require access to laboratories that can carry out biomarker testing to confirm whether a patient is eligible for the treatment.
The potential roll-out of disease modifying treatments presents major challenges for services and has real potential to amplify existing inequities in service access. To anticipate and mitigate these challenges, researchers estimated how many patients are likely to be eligible for disease modifying therapies.
The team compared clinical case notes from over 1,000 people attending either community memory clinics or specialist cognitive services in England. They found that 32% of those attending memory services and 14% of people attending specialist cognitive services would likely be referred for consideration for the new disease modifying treatments.
Researchers found that amyloid biomarker tests were available for people attending specialist cognitive services in the form of specialist scans called PET scans and spinal fluid tests. However, fewer than 1% of people attending community memory clinics had undergone biomarker tests.
Study lead, Professor Rimona Weil, (UCL Queen Square Institute of Neurology, UCLH and Dementia Theme Co-Lead for UCL Partners), said: "Working with clinicians running memory clinics was crucial to this work, meaning that we could get real-world estimates for how many people are likely to be referred for these new drugs for the first time."
While a sizeable proportion of patients attending memory clinics may be referred for therapy for Alzheimer's disease, only a minority are likely to be suitable, once they have undergone biomarker testing.
Consequently, the researchers highlight an immediate need for biomarker testing to ensure that the right patients can be identified for these treatments.
First author, Professor Ruth Dobson, Professor of Neurology at Queen Mary University of London, Consultant Neurologist and Dementia Theme Co-Lead for UCL Partners, said: "The development of disease modifying therapies for dementia has the potential to drive significant service changes. We have seen the impact of this in MS and stroke. It is crucial to understand and plan such changes proactively in order to ensure best care for all people living with dementia, regardless of initial treatment availability and eligibility."
Study co-lead, Professor Catherine Mummery, (UCL Queen Square Institute of Neurology and the National Hospital for Neurology and Neurosurgery), added: "We demonstrate that limited diagnostic resources affect the accuracy of diagnosis and referral habits, and that a collaborative networked approach is critical to developing a functioning treatment service in preparation for these new therapies".
This study was produced by researchers from a network of universities who form the Academic Health Science Centre for UCL Partners and in collaboration with a network of clinicians in memory clinics in London and the South East.
David Thomas, Head of Policy and Public Affairs at Alzheimer's Research UK, said: "New Alzheimer's drugs are finally on the horizon, but for their full potential to be realised, health systems need to be able to offer people with symptoms of dementia an accurate and early diagnosis to find out whether these treatments could benefit them.
"As this research demonstrates, the NHS is a long way from being able to do this testing routinely. It's vital that government invests in the NHS urgently, to ensure we have the right diagnostics and workforce in place to help identify people who could benefit from new treatments should they be deemed safe and effective by the regulators.
"A key part of the solution is cheaper, more scalable diagnostics, such as blood tests, for use in clinical care. Alzheimer's Research UK is partnering with Alzheimer's Society, and the National Institute of Health and Care Research, with funding from Gates Ventures (the private office of Bill Gates) and the players of the People's Postcode Lottery, to carry out research that should provide the evidence needed to make blood tests for diagnosing Alzheimer's a reality in the UK."
