Aducanumab, what this means for the UK
On Monday 7th June 2021 the USA approved the first medication, ever, to combat the underlying cause of Alzheimer’s Disease. Aducanumab, a monoclonal antibody, has been shown to clear amyloid plaques from the brain in individuals with proven levels of abnormally elevated amyloid protein.
The US Food and Drug Administration (FDA) concluded there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients”. FDA 07 June 2021
Can I access aducanumab in the UK?
Currently, the only people accessing aducanumab in the UK enrolled in the Biogen aducanumab international clinical trial in 2018. These volunteers have now joined the open-label part of a clinical trial and are receiving aducanumab. The general public will need to wait until the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) approve its use. For any drug to be available, via the NHS, it must also be approved NICE and The Scottish Medicine’s Consortium to determine its cost effectiveness for the health service and therefore whether or not it is funded for routine use in the NHS.
What will be needed to access aducanumab?
The medication is designed for individuals who have symptoms of mild cognitive impairment (MCI) and evidence of abnormally elevated amyloid protein in the brain. Currently, assessment of amyloid protein in the brain is performed via an amyloid PET scan or analysis of the spinal fluid by lumbar puncture. Unfortunately, PET scans are not an inexpensive procedure and planning and guidance will be required for these diagnostic procedures.
How long will I have to wait until the UK licences aducanumab?
At the time of writing this article, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), are still to receive application for licencing in Britain.
Though approval by the FDA may prompt MHRA approval, many are doubtful we will see this medication available via the NHS, within the next 12 months.
Are there any alternatives to aducanumab?
Currently, several medications from the same family as aducanumab (monoclonal antibodies targeting amyloid plaque) are in final phase international clinical trials. These medications have also shown successful clearance of amyloid protein from the brain, in earlier phase studies. Individuals may screen for these studies, today, in the UK and if they fulfil the eligibility criteria, gain early access to these medications.
All UK Re:Cognition Health Centres are actively enrolling individuals on to these studies, today. Those who screen for these international studies undergo all the assessments required to confirm suitability for treatment, with the same class of medication as Aducanumab and will then enter the clinical trial, in exactly same way as the participants on the Biogen Aducanumab study did at Re:Cognition Health, in 2018.
Initially, the participants will be randomised to receive active medication or placebo and after this randomised portion of the study, will then be invited to join the next part of the study where they are all guaranteed to receive the active medication. Please click here to simply register on line, or to call our expert team to learn about how to join a study at Re:Cognition Health on 0800 802 1030. There is no cost to you for joining a clinical trial and no special requirement for registration to find out more, apart from concern about your memory, for at least the past 12 months. https://recognitionhealth.com/clinical-trials-at-recognition-health/
If aducanumab comes available, can I access it?
Yes, even if you are accessing this type of medication via an international clinical trial, you always retain the right to withdraw from the trial, at any point. Our clinical trial doctors will always do what is best for you, as an individual, to treat your cognitive symptoms.
Where can I access one of these clinical trials whilst awaiting results on aducanumab approval?
Re:Cognition Health’s Clinics in London, Guildford, Plymouth, Birmingham and Washington DC are currently enrolling members of the public into international final phase clinical trials to test new medications designed to slow down and ideally halt the progression of Alzheimer’s disease.
Clinical Trials at Re:Cognition Health
Dr Emer MacSweeney, CEO and Medical Director at Re:Cognition Health comments, “We are absolutely thrilled to be involved in the clinical development programme of Aducanumab and delighted about what this means for people living with Alzheimer’s disease and for their families. This signifies the beginning of a new future, for this common condition. We hope it will give confidence to millions who are worried about their memory and encourage them to seek an early and accurate diagnosis, so they can potentially benefit from these new generation medications. We are so grateful to all of the volunteers who have participated in clinical trials at Re:Cognition Health and proud of the progress we are all making, together.”
If you are worried you or someone you know may have the early signs of Alzheimer’s Disease or you want to understand more about these new generation medications:
Watch this free webinar How to Spot the Early Signs of Alzheimer’s:
https://youtu.be/N1kPUOjLx30
To find out more about the clinical trials available at Re:Cognition Health visit:
Clinical Trials at Re:Cognition Health