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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Dag Aarsland
+44 (0)1234567890
dag.aarsland@kcl.ac.uk


Dr Zunera Khan
+44 (0)1234567890
zunera.2.khan@kcl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Screening with biomarkers for the early detection of Alzheimer’s disease
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Screening with biomarkers for the early detection of Alzheimer’s disease

Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Alzheimer's disease, dementia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Alzheimer’s disease and other diseases affecting the brain cause memory decline and other changes leading to dementia. The number of people with dementia is already high and is expected to increase markedly during the next decades. Lifestyle changes can reduce the risk of dementia, particularly in people with increased risk. Also, there are some new medicines that can slow down memory loss. It is important to diagnose Alzheimer’s and other conditions that cause dementia as soon as possible. This way, people can make changes to lower their risk. Today, the only way to reliably diagnose Alzheimer’s disease is to have an expensive and generally not available imaging scan of your brain, or by testing the fluid around your brain after a procedure called a lumbar puncture. There is a need to find simpler tests for people to access easily. This study will explore a number of relevant tests that can be performed in people’s homes to help us diagnose Alzheimer’s disease. To prevent and treat AD, it is important to gain a deeper understanding of the key factors that influence it. This study will address these important issues by measuring key risk markers (e.g., memory function and hearing, genes, gut microbiome (bacteria living in the gut), blood, brain activity, and mood) over 4 years in adults over the age of 50 years through an online or in-clinic study.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Apr 2024 30 Oct 2025

The study will include digital assessments such as online memory and hearing tests. Other assessments will include giving saliva, stool and finger prick samples. Some people may also undergo brain scans, lumbar puncture and assessment of brain activity. Guidance will be provided with all assessments and kits to allow participants to complete the assessments smoothly.


Older adults aged 50 years and above who are at risk of memory decline and dementia based on other risks including memory decline, lifestyle and medical factors.

You can take part if:



You may not be able to take part if:


1. An established diagnosis of dementia2. Life-threatening physical disease3. Active major psychiatric disorder which is inconsistent with being able to complete informed consent or perform the procedures4. Unable to speak native tongue5. Neurodevelopmental disorder, sensory or other physical impairment or other factor making the person unable to complete the study procedures6. Major disabling stroke, e.g., clinically significant symptoms and/or functional impairment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • South London and Maudsley NHS Foundation Trust
    Institute of Psychiatry, Psychology & Neuroscience 16 De Crespigny Park Denmark Hill
    London
    SE5 8AB

Participants will be taking part in an important research study that could provide valuable new knowledge about new ways to detect people at increased risk for AD.
All researchers have received training in the importance of confidentiality and data protection as per the General Data Protection Regulation (GDPR) (2018) and GCP guidelines, and are made aware of University-specific regulations in handling confidential information. Each participant will have a single identifier (the study participant number). Identifiable personal data (names, addresses, dates of birth) will be recorded and stored separately. This data is needed for patient contact and to send biomarker kits to participants. Only delegated research team members will have access to this information. Digital Data files will be stored on the University of Exeter Servers and on the Institute of Psychiatry, Psychology, and Neuroscience's server in a shared folder to which only the study team will have access. Data for analysis will be provided in an anonymous format. De-identified data will be shared across the PREDICTOM research team for data analysis.
Consent is given in an informed manner, which has also been used successfully to date within the PROTECT infrastructure (https://www.protectstudy.org.uk/). Consent requires participants to complete individual tick boxes for all consent items, a second full consent item, and then a final confirmation of consent which appears on a separate pop-up page on the website. this process avoids participants consenting in error. All consent will be recorded electronically, time- and date-stamped and accompanied by the minimum required personal data to comply with data protection regulations.
Participants may find the cognitive tests challenging. The researchers will reassure participants and explain that these tests are designed to be hard because if they were too easy they would not be able to give useful information about their cognitive abilities.
This study protocol combines established markers like MRI with new ones such as lumbar puncture and optional imaging assessments. It also includes potential markers like fingerprick blood tests that aren't fully validated yet in this population. Alongside traditional clinical and cognitive assessments, this comprehensive approach helps us effectively establish markers for change. Similar studies show that this population is highly motivated to participate in such research, despite the study's intensity. The study participants are able to remain sufficiently committed to remain engaged throughout the study procedures, despite taxing study demand.
Study procedures will be discussed with the research team (study coordinator, nurse and study doctor), similar to a consent process, providing detailed information on each study procedure. The researchers will allow plenty of time to explain and administer the study procedures, and clinic staff at each site will ensure that participants do not feel rushed and understand fully what is happening and why.
Participants will be asked to complete two forms of blood tests (fingerprick tests using an at-home testing kit) and venous blood in the clinic. Whilst this does involve a minor invasive procedure, it is quick and relatively pain-free.
There is a small risk that some people may find certain questions in the memory tests difficult to answer or distressing. All of these tasks will be done at home on their own. Some of the questionnaires include questions about mental health, which may be distressing for some participants, who should contact their general practitioner (GP) or Samaritans (https://www.samaritans.org) if they are worried about their mental health. Mind’s website at www.mind.org.uk has useful resources to help you cope if you are feeling anxious, worried or isolated.
A lumbar puncture (LP) is essential for the collection of cerebrospinal fluid (CSF). The procedure involves introducing a needle to the spine allowing for access to take a sample of CSF. A lumbar puncture is generally a safe procedure, however, as with all medical procedures there is a small risk of side effects. Some people may experience swelling and lower back pain in and around the area where the needle was inserted. The pain normally disappears on its own after a few days or it can be treated with standard pain-relief medication and it’s normally nothing to worry about. A headache is another possible side effect of LP, which can last up to a week. The headache can usually be treated with similar painkillers. Before consenting to a LP, a study doctor will help the participant to understand what this procedure involves and any potential risks associated with it. Any questions and concerns that the participant may have will be also addressed. This procedure will be performed by a clinician (physician or trained specialist nurse) with specific training and experience in administering the procedure. To minimise any discomfort the LP will be performed on a separate day to the rest of the study procedures.

Prof Dag Aarsland
+44 (0)1234567890
dag.aarsland@kcl.ac.uk


Dr Zunera Khan
+44 (0)1234567890
zunera.2.khan@kcl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Stavanger University Hospital and funded by HORIZON EUROPE Framework Programme; COCIR; European Federation of Pharmaceutical Industries and Associations; EuropeBio; MedTechEurope; Vaccines Europe.



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Read full details for Trial ID: ISRCTN11126399
Last updated 18 April 2024

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