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Recruiting NCT04865172

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

Trial Parameters

Condition Frontotemporal Dementia, Behavioral Variant
Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Study Type OBSERVATIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 40 Years
Max Age 85 Years
Start Date 2022-05-20
Completion 2025-05
Interventions
Remote collection of passive and active data for 28 consecutive days

Brief 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.

Eligibility Criteria

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 evid

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