The PROTECT Study

Frequently Asked Questions

Here are some commonly asked questions. If you don't find an answer here then please contact us.

General FAQ

Q: What is the purpose of the study?
This study aims to understand how the functioning of the brain changes as we age. In particular the study will look at how certain genes and lifestyle factors (such as exercise or education) affect the way our brain ages. This will provide valuable information about the brain and could inform future research to prevent conditions such as dementia. The study is being led by King’s College London.

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Q: Why have I been invited?
We are inviting adults over 50 from across the UK to take part in this study. We are looking for 5000 people to join the study for the next ten years.

In order to participate, you will also need to:

  • Have a good working understanding of the English language.
  • Have the ability to use a computer with internet access.
If you have an established diagnosis of dementia from your doctor then unfortunately you will not be eligible for this study.

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Q: Do I have to take part?
It is up to you whether or not to join the study. If you agree to take part, you will then need to read and sign a consent form on the website. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive through your own General Practitioner or local NHS services. This study does not replace those services and if you feel less well during the time you are part of this study it is important that you seek help from your doctor or local health professionals in the usual way.

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Q: Why are we doing the study?
As we get older our brains also begin to age, resulting in a 'slowing down' of abilities such as memory or reasoning. However, we do not fully understand how or why these changes occur. Studies have indicated that certain genes might govern these mental processes, collectively known as ‘cognition’, and how it changes throughout our lives. To date there have been no large studies examining how these genes affect cognition in older adults over the long term. Furthermore, there is some evidence to show that lifestyle factors such as exercise and smoking status could also affect cognition but these links are still unclear and we need to understand more about how genes and lifestyle interact.

It is important to understand what affects our cognition as we age and why it affects people differently. This information could also provide vital knowledge about who is most at risk of dementia, which currently affects 800,000 people in the UK. In order to develop better prevention and treatment for this devastating condition, it is essential to understand cognitive decline and the factors that govern it.

This study will address these important issues by measuring cognition in 5000 adults over 50 over ten years through an online study. Participants will complete a series of tests each year and we will compare their performance with their genes to see how they affect their performance. By combining this work with information about each individual's lifestyle and medical status this study will provide valuable new knowledge about how genetics influence cognition in older adults.

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Q: What will happen if I take part?
If you decide to take part the following steps will happen:
  1. You will be asked to sign the consent form on the next page of the website (a copy of this is at the bottom of the downloadable information sheet).
  2. Once you have registered and signed the consent form you will be asked to provide the following information on the website:
    1. Some general information, such as your age, gender and education.
    2. Your address and contact details to enable us to send you important information and materials.
    3. Information about your current medical status, for example, current diagnoses or prescriptions for any conditions you may have. We will only ask you about conditions that are relevant to this study.
    4. Information on your current lifestyle habits, such as exercise, diet and smoking.
  3. You will then be asked to complete a series of six online cognitive assessments, for example to test your memory, reasoning and attention. These will take around 35 minutes to complete.
  4. One of the cognitive tests can be completed with an ‘informant’. This should be someone who knows you well and spend time with you frequently, such as a spouse, child or close friend. They will be asked to complete questions about you. If you prefer, an alternative version of this test is available in which you would answer the questions yourself.
  5. We will send a saliva sample kit to the address you provided with clear instructions on how to use it. We will ask you to provide a sample to allow us to have a sample of your DNA for the study. This is a very simple, quick and painless procedure. A pre-addressed envelope will be provided for you to post your sample back to us. Unless you opt to take part in additional research studies this information will be for research purposes only and will not be made available to research participants. This is because the medical value of this information is not yet sufficiently understood to give people clear guidance.
  6. You will be asked if you would like to be contacted about taking part in future research including treatment studies. It is difficult to know exactly what new treatments will emerge and be assessed in clinical trials, but studies are likely to look at different ways of preventing cognitive decline in people in middle and later life. Studies may look at a variety of different treatment approaches such as lifestyle approaches (e.g. brain training or exercise) as well as drug therapies. This is entirely optional and you are not obliged to agree to this in order to take part in this cohort study. By signing this part of the consent form you are only agreeing to receive information about future studies and you are under no obligation to take part. For any potential future study you would receive the full details and it would be your choice whether to take part or not.
  7. Each year we will contact you by email and ask you to repeat the cognitive assessments and to update your medical and lifestyle information. We will also keep you up to date with the study through a newsletter and the website.
  8. At the end of the ten-year study we will contact you to let you know the findings of the research.
All the information we collect will be kept anonymous and confidential. We will keep all data for 10 years after the study has finished. We will then destroy it.

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Q: What are the possible benefits and risks of taking part?
This is not a clinical trial and there are no risks associated with any treatment or other intervention. This is an ‘observational’ study, meaning we only wish to observe how you progress over time.

All the information we collect will be stored confidentially, according to the law.

The main advantage of this research is that participants will be taking part in an important research study that could provide valuable new knowledge about how the brain works as we get older. In addition, if you agree to be contacted you will have the opportunity to take part in future important research into the brain, and how we can prevent conditions like dementia.

The NHS Research Ethics Committee has approved this research (London Bridge Ref: 13/LO/1578) and the research will be covered by normal insurance policies at King’s College London.

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Q: What will happen if I don’t want to carry on with the study?
You can withdraw from the study at any time without giving a reason. You can do this through the ‘Withdraw from Study’ link on the website or by contacting us on the study helpline. If you opt to withdraw from the PROTECT study you will be automatically withdrawn from the NIHR Bioresource, and any saliva sample you have provided as part of PROTECT will be destroyed. If you withdraw from the study you can tell us whether you would like us to retain any personal information (email address, home address, GP details, NHS number) collected up to the time you withdraw or whether you would like us to destroy this information. For legal reasons we will retain your name and participant ID to ensure we have a record of your consent when you registered. We will retain all anonymised data that we have collected up to the point you withdraw. This includes all anonymised data from assessments and questionnaires, anonymised genetic data and extracted DNA, which is also entirely anonymised.

There is a very small chance that people taking part in this study may develop cognitive impairment or dementia over the ten year period. In the unlikely event we detect a clinically significant drop in your performance in the study tests we will contact your GP to recommend they arrange an appointment with you to carry out further tests. If you do receive a diagnosis from a medical professional we ask that you let us know through the website or by calling the study helpline. The website will provide information, links and useful contacts that may be helpful to you if this situation arises. However, the study helpline cannot provide detailed or medical support and advice.

If someone develops dementia and loses the capacity to make decisions independently about their involvement in the study, they would then be withdrawn from the study and the NIHR Bioresource. If this happens we will destroy the saliva sample you have provided as part of PROTECT, but we would like to keep all remaining information you have provided up until that date. However, if you would prefer for personal data collected up to this date to be removed from the study you can indicate this on the consent form. You can change your mind about this at any time by following the link on the website or contacting the study helpline. If you decide that you would like us to destroy your personal information please note that we will retain your name and participant ID to ensure we have a record of your consent when you registered.

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Q: Will my taking part in this study be kept confidential?
Research data will be collected online through the study website over the ten year period. All data will be stored securely according to the Data Protection Act (1998) and the security procedures in place at King’s College London. The study database will not include your name, just a study number. Your data will be completely anonymised and it will not be possible to identify you.

During the study we will collect some limited personal information including your address. This information will be stored in a secure separate database. A secure list will link your name, study number and personal details so that we can send and receive your DNA sample and make sure it is linked to information about you. The information will only be available to a small number of researchers on the study team for analysis. We will not pass any information on to any third party.

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Q: What will happen at the end of the study?
At the end of the ten year study period you will complete your final annual assessments on the website. We will contact you to let you know the study has ended and to thank you for your contribution. The results of the study will be published in a scientific journal. We will provide you with a lay summary of our findings in the form of a newsletter. The findings will also be available on the study website. The information collected is totally confidential and no individuals will be identified in any publications.

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Q: What if there is a problem?
If you have a concern about any aspect of this study, information and Frequently Asked Questions are available on the study website. If this does not answer your query you can contact the research team by calling 0207 848 8183.

For independent advice and information you can contact the South London and Maudsley Patient Advice and Liaison Service (PALS):

T: 0800 731 2864

W: www.pals.slam.nhs.uk

E: pals@slam.nhs.uk

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Q: What data will be collected?
To register to take part in the study you will be asked to provide the following information:
  • Agreement that you have read and understood the information about the study
  • Your consent to take part
Once registered we will ask you to complete a questionnaire and assessments at annual intervals. The information collected will include:
  • Basic information about you in a questionnaire format e.g. demographic characteristics, education, lifestyle (including exercise habits), medical history.
  • Cognition function – this is collected by online tests that measure how your brain is functioning.
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Q: Why would you like to receive confidential medical notes from my GP?
These will only be requested with your permission and will be used for information that is directly relevant to the PROTECT study. The medical notes help us to have a more accurate picture of your medical status, so that we can be sure that any changes in your cognition are related to our study, and not to outside influences. We need to control for conditions related to any medication you are taking, and other health conditions. Your notes will be stored anonymously linked only to your cognitive results and not to your personal details.
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Q: Is my data secure?
We are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information.

All personal information is transmitted and stored using the highest industry encryption standards. All assessment data provided is stored anonymously and in a separate database to the personal information which may identify you.

For further details about data security please read our Privacy Policy.

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Q: How will the data collected be used?
The data collected will be used to gather important information about what happens to the brain as we age. Participants in the study will complete assessments to monitor their cognition over time. They will also have the opportunity to take part in innovative studies to answer crucial questions such as:
  • How do key measures, such as memory, language and reasoning change over time as we age?
  • How do our lifestyle choices, including our exercise habits and diet affect our risk of dementia?
  • What role do genetics play in the ageing brain? How do they affect how our brain functions and what is their influence on development of dementia?
  • What are the early signs of dementia and how can they be distinguished from normal ageing?
  • What approaches can be delivered online to influence the ageing process and the development of dementia?

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Q: What will the study achieve?
The study will provide valuable information about how the brain changes with age. It will also investigate which factors in mid-life affect our risk of dementia, such as exercise and diet. This knowledge will help develop better approaches to prevent and treat dementia in the future.

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Q: How long will the study last?
Participants will be invited to complete a series of assessments online which will be repeated annually over the next ten years.

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Q: What happens if I don't complete an assessment on time?
We encourage you to complete asessments by their scheduled due date. However, if you miss a deadline please continue to submit your data as the information you provide is still extremely important to us.

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Q: What is an informant?
An informant is someone we may ask to complete one or more simple assessments about you, for example how well you perform various tasks now compared to ten years ago. You must have known the informant well for at least ten years, for example a friend or family member and they must be age 18 or over.

You will be asked to provide the name and email address of a person who can act as your informant as the final step of registration. We will then invite them to confirm they are willing to act as your informant and if so they will be given their own login account. An informant will not be able to view or access any other information you provide as part of the study nor will you be able to view or access information provided by the informant.

Please note that an informant may already be a participant in the study or can choose to become a participant at a later time if they meet the qualifying criteria.

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Q: I have forgotten my password - what should I do?
If you have lost or forgotten your password please select Forgotten your password on the Sign In page and follow the instructions.

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Q: Can I opt out of the study?
Yes, once registered you can opt out of the study at any time by selecting the Opt out of Study option from the Manage Account menu on your study page. Opting out will permanently delete all your stored personal information. If you wish to continue the study after opting you will need to re-register and re-enter any data previously submitted.

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Q: My question isn't included here - who else can I ask?
Please contact us using details on the Contact Us page and we will try to answer your question.

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DNA samples at the NIHR Bioresource FAQ

Q: What is the NIHR Bioresource and why is it part of PROTECT?
The NIHR Bioresource is a UK-wide facility for collecting and analysing samples from people involved in research, funded by the National Institute of Health Research (NIHR). All DNA samples collected during PROTECT will be processed at the NIHR Bioresource. Participants will also have the opportunity to take part in further research through the NIHR Bioresource in the future. This is entirely optional. For more information about the NIHR Bioresource click here.
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