In the news: Aducanumab – new Alzheimer’s trial results announced
With 850,000 people currently living with dementia in the UK, and this number set to rise to over one million by 2025, urgency is building around dementia research and the hunt for new treatments that could benefit the millions of people around the world living with the condition.
Many potential drugs for Alzheimer’s target amyloid – one of the hallmark proteins that is thought to cause the nerve cell damage that leads to the symptoms of dementia. One example of an anti-amyloid drug being trialled in people is aducanumab, an antibody that tags amyloid and drives its clearance from the brain.
Aducanumab hit the headlines in March 2015, when researchers took the floor at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France. They used this platform to announce initial results from an early-phase clinical trial in people with mild Alzheimer’s disease. This study has grabbed attention once again, as the results discussed at that conference have now been peer-reviewed and published in Nature – a leading scientific publication.
This phase Ib study was only carried out in 165 people, but nevertheless the findings showed evidence that aducanumab can remove the build-up of amyloid in the brain. Although the study was too small to robustly analyse the effect of the drug on cognition, the researchers did see slower decline in memory and thinking skills in people given the drug, providing promising evidence that clearing the amyloid protein could be a successful approach to treating the disease.
This drug is now undergoing a phase III clinical trial called ENGAGE, involving a greater number of participants and currently recruiting in the UK as well as many other countries across the world. It joins many other research studies looking for willing volunteers using the research register Join Dementia Research.
If this study has piqued your interest in getting involved in dementia research, you will be pleased to know that there are currently around 100 dementia research studies looking for volunteers to help them accelerate their research. The best way to find out if you or a loved one may be able to take part is to sign up for Join Dementia Research. When registering, volunteers provide some basic health information that is used to match them up to research studies that they fit the criteria for.
Some studies, including the one for aducanumab, have a strict set of criteria that volunteers need to fulfil before they can take part. In the ENGAGE trial, the researchers are primarily looking for people between 50 and 85 and who have a confirmed diagnosis of mild cognitive impairment (MCI) or mild Alzheimer’s disease. Volunteers fitting this description may be contacted by a research nurse who will carry out a more in-depth screening process.
What might it involve?
As with most clinical trials, volunteers interested in taking part in ENGAGE need to be willing to undergo some assessments. These might include testing for risk genes, having brain scans and blood tests, and doing some memory and thinking tests. In addition to this, taking part in the study would require a time commitment as the volunteers would need to visit their research centre once a month to receive the trial drug, or a dummy injection (placebo). It’s important to remember that not all people on the trial will receive the active drug, others will receive the placebo treatment to act as an important control to show whether the drug really works.
This study is employing some detailed methods to make sure the right people are recruited into the trial, including amyloid brain scanning and genetic testing. Amyloid scanning is a relatively new way of imaging amyloid build-up in the brain and although it is not used clinically, it is starting to be used more and more in dementia research. Below, Prof John O’Brien from the University of Cambridge explains more about amyloid scanning, and its application in dementia research.
Similar to amyloid scanning, testing for genetic risk factors are not available on the NHS because many of the genes discovered so far only have a relatively small effect on risk, meaning that people with them won’t necessarily develop Alzheimer’s. However, these tests can help researchers study those with highest genetic risk and also study whether the treatment has a different effect on people who carry different risk genes. An increasing number of studies are now looking to establish whether volunteers carry the APOE4 risk gene, as this helps the research teams build a more detailed picture of who they’re trying to help.
To find out more about how you can volunteer for dementia research studies, read more about Join Dementia Research on our website. If you prefer, you can also call our Dementia Research Infoline on 0300 111 5 111.