1. Manufacturer details

Trade name: Five Lives SAS
Trade address: 1 Impasse du Palais, 37000 Tours, France

2. What is the Five Lives app?

The Five Lives application provides you with a risk assessment for the likelihood of you developing dementia in the next 10 years, tests for you to assess your cognitive functioning across five domains and a lifestyle coach to track and work on modifying your lifestyle through five distinct lifestyle pillars associated with the risk for dementia: physical activity, sleep, diet, stress & mood and mental stimulation.The Five Lives dementia risk assessment is a CE-marked Class I medical device software under the Medical Device Directive 93/43/EEC.

3. What is the Five Lives Dementia Risk Assessment?

The intended medical use of the Five Lives risk assessment is to identify risk of developing dementia in the next 10 years in individuals aged 50 to 70 in the form of a Brain Baseline Score. We use a questionnaire to learn about your background, health, and lifestyle habits. Based on your answers, our bespoke machine learning algorithm calculates your score. Our algorithm is trained on data from the UK Biobank study, which tracked over 300,000 individuals for 15 years. It is grounded in robust academic research that has highlighted key risk factors linked to developing dementia.

Your Brain Baseline Score indicates your likelihood of developing dementia over the next 10 years relative to other users. It is scaled from 1 to 100. The higher the Brain Baseline Score, the less likely you are to develop dementia in the next 10 years.

The algorithm exceeds the predictive performance of existing gold-standard formulas in the field such as CAIDE and BDSI.‍

The Five Lives app is only suitable to be used by people aged 50 to 70 who have not been diagnosed with mild cognitive impairment (MCI) or dementia.

4. How to install the Five Lives app

The Five Lives app is made available for download in electronic format in the App Store for iOS (Apple) devices and Google Play for Android devices.

The application is estimated to take about 25MB to install for iOS devices, and 100MB for Android devices. However, this number can vary on different types of devices.

5. Five Lives Application Components

Dementia Risk Assessment

Assessment Questionnaire‍

The Five Lives risk assessment is a questionnaire including three modules. Upon completion, you will be provided with information about your future dementia risk, your lifestyle scores, and personalised risk factors. You will also receive further information to understand these factors better.

‍Module 1: About you - This section gathers basic details like your date of birth, sex, height, weight, education level, and your own feelings about your memory.‍

‍Module 2: Your health - This section delves into your health, concentrating on key risk factors linked to dementia. It covers areas like diabetes, stroke, heart disease, depression, untreated vision and hearing issues, gum disease, as well as blood pressure and glucose levels.

‍Module 3: Your lifestyle - This section asks about your lifestyle, covering topics such as smoking, exercise, sleep patterns, diet, stress levels, mood, and mental activities.

‍Assessment Results‍

The results provided to you will include a Brain Baseline Score, Actionable Score, Lifestyle Pillar Scores, and your list of personalised risk and protective factors. You will receive further information to understand these factors better.‍

Brain Baseline Score‍

The Brain Baseline Score, ranging from 1 to 100, indicates your likelihood of developing dementia in the next 10 years compared with other users. It is a holistic score that takes everything into account: the things you can’t change, like genetics, age, and medical history, and the things you can, like your lifestyle habits. A higher score suggests a reduced risk. This score is powered by a unique machine-learning algorithm developed by the team at Five Lives. Our algorithm has been trained on data from the UK Biobank study, which followed over 300,000 people for 15 years, to identify common traits among those who developed dementia.‍

Actionable Score‍

Your Actionable Score represents factors you can control that affect your risk of developing dementia. This includes manageable medical conditions, body mass index, oral health, blood pressure, and lifestyle habits. We determine the contribution of each factor to the score based on a comprehensive review of leading meta-analyses for every risk factor. The higher the score, the less your risk for dementia is driven by factors within your control.‍

Lifestyle Pillar Scores‍

We assign scores to five key lifestyle areas: physical activity, sleep, diet, mood and social interactions, and mental stimulation. Research consistently highlights the importance of these factors for physical and mental health in general. Your scores help pinpoint areas for improvement and are designed to reward even small improvements in lifestyle. You can monitor these scores over time to see your progress.‍

Risk and protective factors‍

We compile a personalised list of risk and protective factors for dementia for you, along with general information on other potential risks. For detailed insights on each factor, please refer to the appropriate tab on the results page. There, you'll find explanations on how each factor might influence your day-to-day brain health, cognitive decline or dementia onset. We've also cited relevant clinical or academic research and provided links to in-app interventions or national healthcare resources for in-depth guidance on managing risk factors.

Cognitive Tests

The app also allows you to assess your cognitive skills using five cognitive tests. One of the tests will also assess long-term memory, which will be required to be completed on day 1, 3 and 7 following test completion. Below is the list of the cognitive tests and the associated cognitive domains they aim to assess.‍

Snap - Verbal fluency‍

‍Snap is a verbal fluency test that measures your ability to produce as many words as possible within a specific category and starting with a specific letter. This test comprises three stages, allocated for a different letter or category. There is a time limit of 60 seconds to complete each of the stages.‍

Breeze - Verbal memory (short term and long term) and numerical abilities‍

‍Breeze is a verbal memory test that tests your ability to recall as many items presented on screen as possible, along with the ability to solve equations quickly. There are short distraction exercises between the learning and the recall phases which assess numerical abilities.In the first phase, 16 words need to be matched to the correct category and image while trying to remember each item presented. In the second phase, equations are presented on the screen, which need to be solved as quickly as possible. In the third phase, all words that can be remembered from phase one will be asked to be written down. In the final phase, words that were not remembered will be primed by their category. You will also be encouraged to complete the recall phases 1, 3, and 7 days after completing this test to assess long term memory.‍

Twist - Speed of processing‍

‍Twist is a test to measure your speed of processing, using a mixture of letters and numbers presented on the screen with specific instructions.In the first stage, 20 digits will be spread around the screen and the task is to tap on the digits from lowest to highest as quickly and accurately as possible. In the second phase, a mix of 20 digits and letters are spread around the screen and the task is to tap on them in order from the lowest digit, followed by the first letter (1a, 2b, 3c etc). The final phase includes distractors in a task design similar to the above.‍

Cast - Spatial and numerical memory‍

‍Cast is a spatial memory test that assesses your ability to remember shapes and their location. Different shapes will be presented in a grid and your task is to recall the location of each shape.‍

Swift - Executive functions‍

‍Swift is a test that assesses executive functions using a series of coloured words that appear on the screen. The meaning of the word either matches the colour of the font or it does not. The task is to answer the colour of the font or the meaning of the word as quickly and accurately as possible.

Results

The results screen for the cognitive tests will provide you with information about your performance on each cognitive domain.

Digital Lifestyle Coach

The Five Lives application now includes a digital lifestyle coach that allows you to monitor your lifestyle on a daily basis; encourages you to make healthy changes through educational content and engaging activities. The digital lifestyle coach has five core pillars: physical activity, sleep, diet, stress & mood and mental stimulation. Every day will unlock an opportunity to complete a daily lifestyle log. The daily log is a short questionnaire that collects information about your habits across each of the five lifestyle pillars which can help you monitor your daily routines and track modifications over time. Each pillar includes educational content explaining the importance of various lifestyle choices in the context of brain health and provides tips on how to maintain healthy habits as well as activities such as brain training games.

6. Warnings

• The information provided within the Five Lives app should not be used as a diagnostic resource and does not substitute an assessment from a qualified medical professional.
• The Five Lives app provides general insights into the overall brain health, based on risk factors currently known to be associated with dementia.
• The Five Lives app is intended to be used by people between the ages of 50 and 69 who have not been diagnosed with MCI or dementia.
• The Digital Lifestyle Coach is not classified as a medical device and is not associated with any medical claims.
• At Five Lives, we are committed to improving our product by using data from the development and validation of machine learning algorithms for the prediction of dementia. Currently, only some questions presented in the assessment are used to provide the results. The remaining data from other questions and the cognitive tests is collected for further research and development purposes.
• We are committed to providing you with a product that meets high-quality standards and performance. However, if our product does not meet your expectations, please do let us know at contact@fivelives.health and we will do our best to resolve any issues as soon as possible.

7. FAQ

How much time should the assessment take?
It can vary between individuals, but we estimate approximately 10 minutes to complete.‍

How much time will the cognitive tests take?
The cognitive tests take approximately 20 minutes to complete.

What are the results based on?
Your Brain Baseline Score, Actionable Score, and Lifestyle Pillar scores, are all calculated using data you provide to us in the questionnaire.
The Brain Health Score, ranging from 1 to 100, indicates your likelihood of developing dementia in the next 10 years compared with other users. The algorithm has been trained on data from the UK Biobank study, which followed over 300,000 people for 15 years, to identify common traits among those who developed dementia.
Your Actionable Score represents factors you can control that affect your risk of developing dementia. This includes manageable medical conditions, body mass index, oral health, blood pressure, and lifestyle habits. We determine the contribution of each factor to the score based on a comprehensive review of leading meta-analyses for every risk factor.
We also assign scores to five key lifestyle areas: physical activity, sleep, diet, mood and social interactions, and mental stimulation.  Your scores help pinpoint areas for improvement and are designed to reward even small improvements in lifestyle. You can monitor these scores over time to see your progress.
After completing each assessment you will also be provided with a list of risk and protective factors relevant to your risk of future dementia. This list is based on existing academic literature highlighting each factor’s association with dementia.

Are there any follow-up assessments?
‍After completing the first assessment, you will be able to complete a second assessment one month after the initial assessment. You will be asked if you agree to be notified when the next assessment becomes available. When one month has passed, the assessment will be available to complete again and those who opted in for notifications will be notified about the assessment becoming available.

Is the product a medical device?
This risk assessment in the product is CE marked and classified as a Class I medical device in the UK and EU.
The cognitive tests and the lifestyle coach do not have an intended medical purpose and are not classified as medical devices.

How can I contact the company if I have an issue or complaint?
‍You can reach us from the Profile tab by going to settings, then ‘help and support’. Alternatively, you can send us an email at contact@fivelives.health.

How is my data stored?
‍Information related to our privacy policy can be found here.‍‍

How can I delete my account?
‍You can automatically delete your account and data from the Settings tab.

What are the terms and conditions?
‍Information related to our terms and conditions can be found here.

What happens if I start the assessment and return more than two weeks later?
Unfortunately, you will have to start the assessment again. For an appropriate evaluation, completing the assessment within two weeks is essential.

What is the suitable age to use the app?
‍The Five Lives app is suitable to be used by people aged 50-69 years.

Can I use the app if I have been diagnosed with MCI or dementia?
‍The Five Lives app is not designed for people diagnosed with MCI or dementia.‍

How can I cancel my Subscription??
‍If you have an iOS device: As an iPhone user, all the payments are administered by Apple. As Apple has charged you and not us, we can do nothing on our side. However, what you should do is go to your:
iPhone Settings > Click on your account (your name at the top of the page) > Subscriptions > select Five Lives from the list and click Cancel Subscription.

If you have an Android device: As an Android user, all the payments are administered by Google. As Google has charged you and not us, we can do nothing on our side. To cancel, follow this guide. ‍

8. More information, feedback and complaints

If you would like to request more information, wish to provide us with feedback or would like to make a complaint please send us an email at contact@fivelives.health.