DementiaCODEC-IINCT07051408
Predictors Of Cognitive Decline Using Digital Devices
An observational study of Dementia and Mild Cognitive Impairment (MCI), run by University College, London at 1 site in United Kingdom.
Trial summary
The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD)
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2022to 31 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include patients of Essex Memory Clinics within the Essex Partnership University NHS Foundation Trust which serves older adults living in greater London and Essex areas. Participants will be patients with cognitive complaints, mild cognitive impairment or dementia, and their partners/carers/family members/friends as controls.
Who may be able to join
- Patients who present to the Essex Memory Clinic and their relatives or carers
- Capacity to provide written informed consent
- Sufficient proficiency in English to understand study documents and use the digital devices
- Own a compatible smartphone (Android 7.0 or higher / iOS 12.2 or higher). If participants own a smartphone which is not a compatible device (i.e. prior to Android 7.0 or iOS 12.2), a new handset will be provided to them, as long as they are willing to use this as their primary phone.
- Ability to use a smartphone and EDoN digital devices, either alone, or with appropriate support (carer, partner, family member, etc). Support would involve reminding participants to complete study tasks and to charge / wear devices.
- Able to connect to the internet using their smartphone at home. Note: In order to use the Dreem headband, participants will additionally require a home WiFi connection. However, participants without a WiFi connection will still be able to join the study and will not be asked to use the Dreem headband.
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- For people with a diagnosis of dementia, a carer, partner or family member willing to support their participation in the study by reminding patients to complete study tasks and to charge/wear their devices
- For patients who do not have a record of neurocognitive and physical assessments outlined in section 4.5.3, they must be willing to undergo these additional assessments
- For the blood donation sub study only: consented to participate in the main CODEC II study.
- For the qualitative sub study only: able to use a phone or video-conferencing platform to participate in the interviews
- Aged 40+ years
Who cannot join
- Patients with active major psychiatric disorder which requires regular reviews by secondary care, for example schizophrenia, schizoaffective disorder or bipolar affective disorder
- Patients under end-of-life care
- Previous sensitivity or allergic skin reaction to latex, rubber or plastics
- Do not have a personal smartphone with internet access
- Participating in a clinical trial of an investigational medicinal product
- Not meeting all inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors Of Cognitive Decline In Attenders Of Essex Memory Clinic From Digital Devices Using Classical Statistical Methods, Machine Learning And Disease Progression Modelling
The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. The digital technology used will include a smartwatch, a sleep headband and two smartphone applications, which have been selected as part of the Early Detection of Neurodegenerative Disease (EDoN) initiative. The investigators will also investigate how the digital data can be analyzed together with routinely captured clinical data using machine learning models, a complex type of statistical analysis.
The aim of the wider EDoN initiative is to combine digital and clinical data to develop machine learning models which can predict individuals' risk of developing dementia decades before the onset of symptoms.
Read the detailed description
Study Design \& Methods of Data Collection: This study is designed as an observational, pilot and feasibility study. Recruitment will be over 18 months with clinical data collected at baseline and up to 5 years follow up, and digital data collected at baseline, 3, 6, 9 and 12 months.
Setting: Essex Memory Clinics within the Essex Partnership University NHS Foundation Trust which serves older adults living in greater London and Essex areas.
Participants: The investigators aim to recruit a minimum of 100 participants, comprising of a 3:1 ratio of patients to controls respectively (refer to section 6 for eligibility criteria). Participants will include patients of the memory clinic with cognitive complaints, mild cognitive impairment or dementia, and their partners/carers/family members/friends as controls. As this is a feasibility study, this sample is not based on a power calculation, but findings will inform future work in this area. Sampling will follow a convenience strategy, appropriate for a feasibility study.
Methods: Overall feasibility of implementing digital tools within a clinical population will be evaluated through a combination of direct usage data from the devices and apps and via questionnaires. Digital tools (Fitbit, Dreem headband, Mezurio app, Longevity app) will be provided to participants at a baseline visit at the participant's home.
The broad, but not exclusive, areas of interest will include:
- Participant retention and attrition rates of each digital tool
- Comparison of 14- and 28-day Mezurio schedules
- Practicalities of distribution, collection and storage of the digital technologies
- Approaches to train participants on use of digital technologies
- Technical support needs and uptake by participants
- Ease of transfer and integration of digital data
- Assessment of the study management platform (Fluvial)
Digital Tools: In order to develop disease-specific fingerprint models, it is necessary to collect a wide range of measures which may be affected by early disease processes. Therefore, a combination of digital tools will be utilised, including remote active and passive smartphone-based assessments and remote passive data collection with devices (e.g., a smartwatch and an EEG headband). These technologies will be targeted at functions with a direct relationship to the brain-regions first affected by dementia-related pathology in addition to using digital devices to measure new signals of interest. The investigators will aim to keep the participant burden as low as possible by mainly including passive measures (e.g., monitoring sleep EEG) and by limiting the amount of time participants are engaged in active assessments (e.g., a smartphone-based memory test) to approximately 10 minutes per day.
- Conditions
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Rapid Eye Movement Sleep Behavior Disorder, Healthy Control Patients of the Same Age
- Keywords
- Digital Devices, Diagnosis, Prediction, Prognosis, Dementia Risk, Machine Learning, Wearables, Blood Based Biomarkers
- Medical subject headings
- Dementia, Cognitive Dysfunction, REM Sleep Behavior Disorder, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint
The investigators will assess the feasibility of capturing digital data from digital technologies that have been selected as part of the EDoN initiative. This will be achieved by assessing the mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint. In addition, a subset of participants who consented to the main study will be invited to participate in a qualitative sub-study to explore the perspectives of people with cognitive impairment and their partners, carers or family members on the use of digital devices included in the EDoN toolkit.
Measured: 0, 3, 6, 9, and 12 months
Mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules
One of the digital technologies being evaluated/utilised in the study is a cognitive testing application called 'Mezurio' created by Dr Chris Hinds at the University of Oxford. Participants will be asked to install Mezurio on their smartphone at baseline and complete a range of short tasks over a period of either 14 or 28 consecutive days during the 12 month study period. Participants on the 14 day schedule will repeat the assessments at 3 month intervals; participants on the 28 day schedule will repeat the assessments at 6 month intervals. Participants will be allocated to each assessment period randomly. The investigators will assess the mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules.
Measured: 0, 3, 6, 9, and 12 months
Secondary outcomes (1)
Incident subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia
In participants who are patients (recruited from memory clinics), the investigators will record new diagnoses that represent a progression/worsening of cognitive decline. For example, in patients with SCD, the investigators will record incident MCI/dementia, whereas for patients with MCI, only incident dementia will be recorded.
In participants who are relatives/carers (i.e., healthy controls), the investigators will record any new cognitive diagnoses, including SCD, MCI and/or dementia. These data will be used to achieve the broader aims of the study (please see Study Description for details).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start19 Jul 2022
- Primary completion18 Nov 2025
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Zuzana Walker, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051408
- Sponsor's protocol ID
- 144168
- Other IDs
- IRAS ID: 289028
- Acronym
- CODEC-II
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Digital device data, demographic data and some clinical data.
Publications
Wilson S, Beswick E, Morrell R, Bhogal S, Tolley C, Whitfield T, Wing K, Mc Ardle R, Hassan N, Walker Z, Slight S. Acceptability of wearable technology for the early detection of dementia-causing diseases: perspectives from the CODEC II cohort. BMC Digit Health. 2025;3(1):55. doi: 10.1186/s44247-025-00191-3. Epub 2025 Aug 29.
PubMed 40893385
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Of Cognitive Decline In Attenders Of Essex Memory Clinic From Digital Devices Using Classical Statistical Methods, Machine Learning And Disease Progression Modelling
- ClinicalTrials.gov ID
- NCT07051408
- Acronym / sponsor ID
- CODEC-II / 144168
- Conditions
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Rapid Eye Movement Sleep Behavior Disorder, Healthy Control Patients of the Same Age
- Keywords
- Digital Devices, Diagnosis, Prediction, Prognosis, Dementia Risk, Machine Learning, Wearables, Blood Based Biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. The digital technology used will include a smartwatch, a sleep headband and two smartphone applications, which have been selected as part of the Early Detection of Neurodegenerative Disease (EDoN) initiative. The investigators will also investigate how the digital data can be analyzed together with routinely captured clinical data using machine learning models, a complex type of statistical analysis.
The aim of the wider EDoN initiative is to combine digital and clinical data to develop machine learning models which can predict individuals' risk of developing dementia decades before the onset of symptoms.
Detailed description
Study Design \& Methods of Data Collection: This study is designed as an observational, pilot and feasibility study. Recruitment will be over 18 months with clinical data collected at baseline and up to 5 years follow up, and digital data collected at baseline, 3, 6, 9 and 12 months.
Setting: Essex Memory Clinics within the Essex Partnership University NHS Foundation Trust which serves older adults living in greater London and Essex areas.
Participants: The investigators aim to recruit a minimum of 100 participants, comprising of a 3:1 ratio of patients to controls respectively (refer to section 6 for eligibility criteria). Participants will include patients of the memory clinic with cognitive complaints, mild cognitive impairment or dementia, and their partners/carers/family members/friends as controls. As this is a feasibility study, this sample is not based on a power calculation, but findings will inform future work in this area. Sampling will follow a convenience strategy, appropriate for a feasibility study.
Methods: Overall feasibility of implementing digital tools within a clinical population will be evaluated through a combination of direct usage data from the devices and apps and via questionnaires. Digital tools (Fitbit, Dreem headband, Mezurio app, Longevity app) will be provided to participants at a baseline visit at the participant's home.
The broad, but not exclusive, areas of interest will include:
- Participant retention and attrition rates of each digital tool
- Comparison of 14- and 28-day Mezurio schedules
- Practicalities of distribution, collection and storage of the digital technologies
- Approaches to train participants on use of digital technologies
- Technical support needs and uptake by participants
- Ease of transfer and integration of digital data
- Assessment of the study management platform (Fluvial)
Digital Tools: In order to develop disease-specific fingerprint models, it is necessary to collect a wide range of measures which may be affected by early disease processes. Therefore, a combination of digital tools will be utilised, including remote active and passive smartphone-based assessments and remote passive data collection with devices (e.g., a smartwatch and an EEG headband). These technologies will be targeted at functions with a direct relationship to the brain-regions first affected by dementia-related pathology in addition to using digital devices to measure new signals of interest. The investigators will aim to keep the participant burden as low as possible by mainly including passive measures (e.g., monitoring sleep EEG) and by limiting the amount of time participants are engaged in active assessments (e.g., a smartphone-based memory test) to approximately 10 minutes per day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include patients of Essex Memory Clinics within the Essex Partnership University NHS Foundation Trust which serves older adults living in greater London and Essex areas. Participants will be patients with cognitive complaints, mild cognitive impairment or dementia, and their partners/carers/family members/friends as controls.
Key inclusion criteria (11 listed)
- Patients who present to the Essex Memory Clinic and their relatives or carers
- Capacity to provide written informed consent
- Sufficient proficiency in English to understand study documents and use the digital devices
- Own a compatible smartphone (Android 7.0 or higher / iOS 12.2 or higher). If participants own a smartphone which is not a compatible device (i.e. prior to Android 7.0 or iOS 12.2), a new handset will be provided to them, as long as they are willing to use this as their primary phone.
- Ability to use a smartphone and EDoN digital devices, either alone, or with appropriate support (carer, partner, family member, etc). Support would involve reminding participants to complete study tasks and to charge / wear devices.
Key exclusion criteria (6 listed)
- Patients with active major psychiatric disorder which requires regular reviews by secondary care, for example schizophrenia, schizoaffective disorder or bipolar affective disorder
- Patients under end-of-life care
- Previous sensitivity or allergic skin reaction to latex, rubber or plastics
- Do not have a personal smartphone with internet access
- Participating in a clinical trial of an investigational medicinal product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint
Time frame: 0, 3, 6, 9, and 12 months
The investigators will assess the feasibility of capturing digital data from digital technologies that have been selected as part of the EDoN initiative. This will be achieved by assessing the mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint. In addition, a subset of participants who consented to the main study will be invited to participate in a qualitative sub-study to explore the perspectives of people with cognitive impairment and their partners, carers or family members on the use of digital devices included in the EDoN toolkit.
Mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules
Time frame: 0, 3, 6, 9, and 12 months
One of the digital technologies being evaluated/utilised in the study is a cognitive testing application called 'Mezurio' created by Dr Chris Hinds at the University of Oxford. Participants will be asked to install Mezurio on their smartphone at baseline and complete a range of short tasks over a period of either 14 or 28 consecutive days during the 12 month study period. Participants on the 14 day schedule will repeat the assessments at 3 month intervals; participants on the 28 day schedule will repeat the assessments at 6 month intervals. Participants will be allocated to each assessment period randomly. The investigators will assess the mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules.
1 secondary outcome
Incident subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 40893385Wilson S, Beswick E, Morrell R, Bhogal S, Tolley C, Whitfield T, Wing K, Mc Ardle R, Hassan N, Walker Z, Slight S. Acceptability of wearable technology for the early detection of dementia-causing diseases: perspectives from the CODEC II cohort. BMC Digit Health. 2025;3(1):55. doi: 10.1186/s44247-025-00191-3. Epub 2025 Aug 29.
- Individual participant dataSharing planned: Yes. Digital device data, demographic data and some clinical data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuzana Walker, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment (MCI), run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint (time frame: 0, 3, 6, 9, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.