ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions — @HOME  

Alzheimer Disease Clinical Trial

Official title: ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed at Patients With Neurodegenerative Dementias and Their Caregivers

Status Not yet recruiting

Clinical Trial Summary

ECOCAPTURE@HOME is a study which is currently being developed with the objective to capture the behavioral signature of apathy in everyday life context through remote monitoring of participants' behavior for about one month. Participants will not only be patients with apathy but also their spouse caregiver. Behavioral markers of apathy will be extracted from a combination of: 1/ objective physiological data from sensors on a bracelet worn by participants; 2/ subjective data filled by the caregiver through an application. Thus investigators will collect a pool of metrics and show they can measure three assumed behavioral markers of apathy (daytime activity, quality of sleep and emotional arousal), which in turn allow to predict caregiver's perception of the dyad's psychological state. The final goal is to lay the foundations for the development of a clinical tool for the remote follow-up of patient-caregiver couples.

Clinical Trial Description

Apathy, a common neuropsychiatric symptom associated with dementia, has a strong impact on both patients' and caregivers' quality of life. In spite of its debilitating consequences, apathy is still poorly understood and hard to define or measure objectively. The overall objective of the ECOCAPTURE programme is to define a precise behavioural signature of apathy, assessed by a multi-modal and ecological approach. This protocol called "ECOCAPTURE@HOME" aims to validate a novel method for the remote measurement of behavioural markers of apathy. The final purpose of such a protocol being to improve the diagnosis and long-term follow-up of apathy.

Investigators plan to recruit 60 couples aged between 40 and 85 years old and divided into three groups of dyads: one group of 20 patient-caregiver dyads in which patients suffer from the behavioral variant of Fronto-Temporal Dementia (bvFTD), one group of 20 patient-caregiver dyads in which patients suffer from Alzheimer Disease (AD) and one group of 20 healthy control couples. All recruited dyads will be followed in their everyday life for 28 consecutive days via a multi-sensor wearable bracelet (worn by both partners of the dyad) collecting passive behavioural data. Active behavioural data will also be collected using questionnaires available on a smartphone application (completed by caregiver in patient-caregiver dyads). Investigators will thus validate a measurement model for three theoretical behavioural markers of apathy (i.e., daytime activity, quality of sleep and emotional arousal) using a pool metrics extracted from passive behavioural data (acceleration, electrodermal activity and blood volume pulse) completed by active behavioural data (describing behaviour at meals, wake and bedtime). Moreover, investigators will investigate this measurement model on both a daily and a monthly scale and will attempt to show that the measured behavioural markers of apathy can predict caregiver's perception of the dyad's psychological state (collected through questionnaires) on these two time-scales.

This project carries great potential to improve both patients' care and caregivers' social support. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Frontotemporal Dementia, Behavioral Variant
• Pick Disease of the Brain

• NCT number: NCT04865172
• Study type: Observational
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Richard Levy, MD, PhD
• Phone: 01 49 28 24 32
• Email: richard.levy@aphp.fr
• Status: Not yet recruiting
• Start date: September 2021
• Completion date: September 2023