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ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions
ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

NCT04865172

CompletedN/A

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Conditions: Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease

Interventions: Remote collection of passive and active data for 28 consecutive days

Countries: France

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 overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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 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
Locations (1)
  • Paris, France