RECRUITINGOBSERVATIONAL

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

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

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria for patients: 1. Diagnosis of bvFTD according to Rascovsky's international criteria for the bvFTD group / diagnosis of AD according to Dubois's international criteria for the AD group; 2. No evidence of any other cerebral pathology; 3. A Mini-Mental State Evaluation (MMSE) score superior or equal to 10 (to minimise the effect of confounding factors related to very severe cognitive impairment); 4. Aged between 40 and 85; 5. No evidence of any psychiatric condition and a Montgomery-Åsberg Depression Rating Scale (MADRS) score inferior to 20 (to avoid confusion between depression and apathy); 6. No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect); 7. No major physical disability disrupting mobility; 8. No heart pacemaker (which would compromise heart rate measuring). Inclusion Criteria for caregivers and partners of healthy control dyads: 1. Aged between 40 and 85; 2. No evidence of any psychiatric condition; 3. A MADRS score inferior to 20; 4. No evidence of excessive consumption of psychotropic drugs; 5. No major physical disability disrupting mobility; 6. No heart pacemaker. Who Should NOT Join This Trial: 1. Persons in detention by judicial or administrative decision 2. Person who is subject to a legal protection order 3. Person submitted to an exclusion period due to the participation to another research Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria for patients: 1. Diagnosis of bvFTD according to Rascovsky's international criteria for the bvFTD group / diagnosis of AD according to Dubois's international criteria for the AD group; 2. No evidence of any other cerebral pathology; 3. A Mini-Mental State Evaluation (MMSE) score superior or equal to 10 (to minimise the effect of confounding factors related to very severe cognitive impairment); 4. Aged between 40 and 85; 5. No evidence of any psychiatric condition and a Montgomery-Åsberg Depression Rating Scale (MADRS) score inferior to 20 (to avoid confusion between depression and apathy); 6. No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect); 7. No major physical disability disrupting mobility; 8. No heart pacemaker (which would compromise heart rate measuring). Inclusion Criteria for caregivers and partners of healthy control dyads: 1. Aged between 40 and 85; 2. No evidence of any psychiatric condition; 3. A MADRS score inferior to 20; 4. No evidence of excessive consumption of psychotropic drugs; 5. No major physical disability disrupting mobility; 6. No heart pacemaker. Exclusion Criteria: 1. Persons in detention by judicial or administrative decision 2. Person who is subject to a legal protection order 3. Person submitted to an exclusion period due to the participation to another research

Treatments Being Tested

OTHER

Remote collection of passive and active data for 28 consecutive days

Passive sensor data: collected continuously for 28 days, from a multi-sensor wearable bracelet worn by each member of the dyad; Active questionnaire data: collected once a week during the four weeks of monitoring (and at the end of the 28 days for patient-caregiver dyads), from questionnaires filled by one partner of the dyad (for patient-caregiver dyads, this will be the caregiver) using a smartphone application.

Locations (1)

ICM, Hôpital Salpêtrière

Paris, France