The ‘EARLY’ Study
Introduction by Dr Pearson on The ‘EARLY’ Study
Alzheimer’s disease (AD) is a neurodegenerative disease that causes increasing damage to the nerves in the brain with symptoms, referred to as cognitive decline, such as difficulty making decisions, memory loss, and behavioural problems such as anxiety. Specific protein fragments (Amyloid-beta), which are sometimes linked with nerve damage, are found in the brain. These protein fragments are thought to be an important early marker (biomarkers) for Alzheimer’s disease.
What are the main aims of the EARLY Study?
This is a commercial trial, sponsored by Janssen. The main aim of this study is to find out if treatment with a new study drug developed by the sponsor, when compared to placebo, slows down cognitive decline by reducing the amount of amyloid-beta fragments in the brains of currently healthy volunteers. Clearing of amyloid could have a beneficial impact on the prevention of clinical Alzheimer’s Disease, which the EARLY study may further help investigate.
As part of this study participants are divided into three groups: there are two groups with different treatment doses of the drug and there is also a placebo arm, which is a dummy tablet. Both the volunteer and the clinical trial team are all blinded to which arm participants are in so that none of them know who is on treatment or not.
What does it involve for the participant?
Before the study itself can take place and participants are being divided into either one of the three groups explained above, volunteers will be screened for eligibility for participation in the study. The screening phase of the study first involves a health check which includes blood tests.
Participants then have a brain scan and after this has taken place, the volunteer has an assessment to find out about the presence of amyloid in his/her brain. This may be either a specialist brain scan, called an ‘amyloid PET scan’, or through a sample of the fluid around the brain as cerebrospinal fluid may need to be obtained to be analysed for amyloid levels.
If amyloid is found to be present, and the participant has successfully passed the other screening assessments, then the volunteer can be considered eligible for the trial.
How long is the study for?
The study is predicted to last for 5 years, with the research team providing support throughout the trial.
What do you hope the outcomes of the study will be?
Dr Pearson: ‘There is great interest in this study in the world of dementia research as the study is trying to see if clinical Alzheimer’s Disease could be preventable.
This study is part of the global research endeavour to find treatment for Alzheimer’s disease and to provide ways of preventing this global epidemic.’
Where is the study based?
Dr Pearson: ‘The study is an international trial, so as well as having nine participating research centres located in the UK, other countries are involved in the study as well, with the purpose to advance the understanding of Alzheimer’s Disease.
The Janssen’s EARLY Study currently has the following active sites in the UK:
• North Thames & London
• Greater Manchester
• West of England
• North East
• South West Peninsula
How does Join Dementia Research help with recruitment to studies?
Dr Pearson: ‘Join Dementia Research has been an incredibly exciting initiative. To be able to develop new treatments and assess the effectiveness of these interventions, we will need to recruit 20 % of people who have a diagnosis of dementia to research studies, as we move forwards. This is an enormous challenge for all of us in the research field and Join Dementia Research provides us with the support to help meet this target.’
Why is dementia research important now?
Dr Pearson: ‘There is so much to find out and understand about how our brains work and what goes wrong in diseases such as dementia. These diseases are rising in prevalence as the whole population ages, which is a consequence of our success at helping everyone to live longer. As this disease becomes more prevalent the pressure to find treatments will become intense. There is literally no time to lose.’
About the Chief Investigator
Dr Stephen Pearson is Chief Investigator for the EARLY study in the UK. He will be conducting this study at his memory research centre which is located in Plymouth, Devon.
He said “all members of the research team delivering this study in the UK are really excited to be delivering world class research that volunteers have the opportunity to take part in here in the UK”.
Dr Pearson’s contact details are firstname.lastname@example.org
You can see if you are eligible for this study, as well as others around the nation, by logging into your Join Dementia Research account.
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