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Take a look at a selection of our recent media coverage:

NHS dementia services may not deliver potential of disease-modifying therapies and testing

20th June 2024

NHS dementia services will need to make big changes to identify which patients may be eligible for new disease-modifying therapies such as donanemab and lecanemab, which are likely to be available later this year.

Currently less than 1% of patients in NHS memory clinics had amyloid biomarker testing performed, and this will need ‘urgent’ service development if patients are to access newer treatments once approved.

A retrospective study of 1,017 patients who had attended either memory services or a specialist cognitive service in London found a substantial number of patients could be eligible for disease-modifying therapies if they become available on the NHS.

Of the 517 attending a memory clinic, researchers found that 32% would likely be considered for the drugs, yet in this setting patients did not have access to tests they would need before starting treatment.

In the specialist service where amyloid biomarker tests were available, only 14% of the 500 patients would be potentially eligible for treatment, the researchers reported in the Journal of Neurology, Neurosurgery and Psychiatry.

They noted that in the current set up of psychiatry-led community memory clinics – where most dementia care is delivered – it is extremely unlikely the disease-modifying therapies would be administered.

Their adoption will require additional staff and training across imaging, diagnostics and pathology, and other clinical services, the team from Queen Mary University of London said.

It will also require access to laboratories that can carry out biomarker testing to confirm eligibility, they added. 

There is also ‘real potential’ to amplify existing inequities in service access, they noted.

Both donanemab and lecanemab have been reported in clinical trials to slow the progress of Alzheimer’s disease in its early stages. Approval for use on the NHS is expected this summer.

Professor Ruth Dobson, professor of neurology at Queen Mary University of London and consultant neurologist at Barts Health NHS Trust, 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 [multiple sclerosis] 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 lead, Professor Rimona Weil, consultant neurologist at the UCL Dementia Research Centre and honorary consultant neurologist at the National Hospital for Neurology, said the researchers had worked with clinicians running memory clinics was crucial to get ‘real-world estimates for how many people are likely to be referred for these new drugs for the first time’.

David Thomas, head of policy and public affairs at Alzheimer’s Research UK, added: ‘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.’

A version of this article was originally published by our sister publication Pulse.

Milestone reached as donanemab shown to slow progress in early Alzheimer‘s disease

18th July 2023

Donanemab has been found to slow the progression of early symptomatic Alzheimer’s disease after 76 weeks of treatment, according to the findings of a phase 3 randomised trial.

The monoclonal antibody donanemab, which targets the insoluble, modified, N-terminal truncated form of β-amyloid present only in brain amyloid plaques, was given to patients with early symptomatic Alzheimer disease with amyloid and tau pathology. Nearly half of those given the drug showed no signs of disease progression after 12 months.

Commenting on the research, Dr Richard Oakley, associate director of research and innovation at the Alzheimer’s Society, said:  ‘This is truly a turning point in the fight against Alzheimer’s and science is proving that it is possible to slow down the disease. Treatments like donanemab are the first steps towards a future where Alzheimer’s disease could be considered a long-term condition alongside diabetes or asthma.‘

Published in the Journal of the American Medical Association, participants of the TRAILBLAZER-ALZ 2 trial were categorised as having either low/medium or high tau pathology and randomised 1:1 ratio to receive donanemab or a placebo intravenously every four weeks for 72 weeks. 

The primary outcome of interest was the change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks. There were a number of secondary outcomes, one of which was the change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score.

Donanemab and disease progression

A total of 1,736 participants (57.4% women) with a mean age of 73.0 years were recruited. Some 68.1% had low/medium tau pathology and 76% completed the trial.

The least-squares mean (LSM) change in iADRS score at 76 weeks was −10.2 with donanemab and −13.1 with placebo (difference = 2.92, p < 0.001) for the combined population. In addition, the LSM change in CDR-SB score at 76 weeks was 1.72 with donanemab and 2.42 with placebo (difference = −0.7 p <0 .001) in the combined population.

Furthermore, an estimated 47% of participants receiving donanemab had no change in the CDR-SB at one year (i.e. no disease progression) compared with 29% of participants receiving the placebo.

The trial also revealed how donanemab treatment significantly reduced brain amyloid plaque at all time points assessed, with 80% (low/medium tau population) and 76% (combined population) of participants achieving amyloid clearance at week 76.

The level of clearance beyond 76 weeks, as well as levels of Alzheimer disease biomarkers, are currently being studied in an ongoing extension phase.

In subgroup analysis, among participants with mild cognitive impairment, donanemab slowed decline by 60% on iADRS and 46% on CDR-SB. Additionally, in an analysis based on participant’s age, in those under 75 years, donanemab slowed decline by 48% on iADRS and 45% on CDR-SB, whereas the drug slowed decline by 25% on iADRS and 29% on CDR-SB in those over 75 years.

Liana Apostolova, distinguished professor in Alzheimer’s Disease research and professor in neurology, radiology, medical and molecular genetics at Indiana University School of Medicine, said: ‘These results demonstrate that diagnosing and treating people earlier in the course of Alzheimer’s disease may lead to greater clinical benefit. The delay of disease progression over the course of the trial is significant and will give people more time to do such things that are meaningful to them.‘

Dr Oakley added: ‘It’s also important to note that side effects did occur, although serious side effects only occurred in 1.6% of people receiving the drug. Regulators will need to balance these side effects against the benefits of the drug.

‘We should also note that the majority of people who took part in this trial were white – it’s crucial that in future trials we see more diversity to prove that new drug treatments have similar effects for everyone living with Alzheimer’s disease.‘

Early diagnosis imperative

Highlighting the ‘defining moment for dementia research‘, Kate Lee, Alzheimer’s Society CEO, added: ‘New treatments could mean nothing if we don’t fix dementia diagnosis. We estimate around 720,000 people in the UK could potentially benefit from these emerging new Alzheimer’s disease treatments if they’re approved for use here. But the NHS is simply not ready to deliver them.

‘Everyone living with dementia deserves access to a speedy, accurate diagnosis to get the support and treatments they need, now and in the future.‘

This comes shortly after news that diagnosing Alzheimer’s disease through the use of blood biomarkers could transform care for patients after new proposed guidelines were presented at the International Alzheimer’s Congress in Amsterdam.