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ACTIVE NOT RECRUITING

NCT07051408

Predictors Of Cognitive Decline Using Digital Devices

Sponsor: University College, London

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

135

Start Date

2022-07-19

Completion Date

2025-10

Last Updated

2025-07-10

Healthy Volunteers

Yes

Conditions

Dementia Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)Rapid Eye Movement Sleep Behavior Disorder Healthy Control Patients of the Same Age

Inclusion Criteria: 1. Patients who present to the Essex Memory Clinic and their relatives or carers 2. Capacity to provide written informed consent 3. Sufficient proficiency in English to understand study documents and use the digital devices 4. 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. 5. 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. 6. 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. 7. 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 8. 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 9. For the blood donation sub study only: consented to participate in the main CODEC II study. 10. For the qualitative sub study only: able to use a phone or video-conferencing platform to participate in the interviews 11. Aged 40+ years Exclusion Criteria: 1. Patients with active major psychiatric disorder which requires regular reviews by secondary care, for example schizophrenia, schizoaffective disorder or bipolar affective disorder 2. Patients under end-of-life care 3. Previous sensitivity or allergic skin reaction to latex, rubber or plastics 4. Do not have a personal smartphone with internet access 5. Participating in a clinical trial of an investigational medicinal product 6. Not meeting all inclusion criteria

Locations (1)

St Margarets Hospital

Epping, Essex, United Kingdom