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: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• 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;

• No evidence of any other cerebral pathology;

• 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);

• Aged between 40 and 85;

• 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);

• No evidence of excessive consumption of psychotropic drugs - for instance benzodiazepines, sleeping pills, etc. (due to their tranquilising effect);

• No major physical disability disrupting mobility;

• No heart pacemaker (which would compromise heart rate measuring).

• Aged between 40 and 85;

• No evidence of any psychiatric condition;

• A MADRS score inferior to 20;

• No evidence of excessive consumption of psychotropic drugs;

• No major physical disability disrupting mobility;

• No heart pacemaker.

Locations
Other Locations
France
ICM, Hôpital Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Richard Levy, MD, PhD
richard.levy@aphp.fr
01 49 28 24 32
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2025-05
Participants
Target number of participants: 120
Treatments
Patient-caregiver dyads, patients with behavioural variant frontotemporal dementia
20 patient-caregiver dyads, patients with behavioural variant frontotemporal dementia
Patient-caregiver dyads, patients with Alzheimer disease
20 patient-caregiver dyads, patients with Alzheimer disease
Healthy control dyads
20 healthy control dyads
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov