Predictors Of Cognitive Decline Using Digital Devices

NCT07051408 | Active Not Recruiting

• 2 other identifiers: 144168IRAS ID: 289028
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  0, 3, 6, 9, and 12 months

Secondary Outcomes (1)

• Incident subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia

  12 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• University of Oxford: collaborator

Study Sites (1)

St Margarets Hospital

Epping, Essex, CM16 6TN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40893385 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Cellular Fraction

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; REM Sleep Behavior Disorder; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zuzana Walker, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 4, 2025
• Study Start: July 19, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Q1 2027 for five years
• Access Criteria: Bona fide researchers

Locations

GB (1)