NCT04865172 ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions
| NCT ID | NCT04865172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Frontotemporal Dementia, Behavioral Variant |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-05-20 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Richard Levy, MD, PhD
PRINCIPAL INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT04865172 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Frontotemporal Dementia, Behavioral Variant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04865172 currently recruiting?
Yes, NCT04865172 is actively recruiting participants. Contact the research team at richard.levy@aphp.fr for enrollment information.
Where is the NCT04865172 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04865172 clinical trial?
NCT04865172 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Richard Levy, MD, PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 120 participants.