CompletedNot Applicable

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

France44 participantsStarted 2022-05-20

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This ECOCAPTURE study has already been completed — is there any published data from it that might be relevant to understanding how apathy is tracked in someone with my diagnosis of Alzheimer's disease or frontotemporal dementia?
2Since this study measured things like body movement, electrodermal activity, sleep times, and meal-related behaviors over four weeks using wearable sensors, could a similar monitoring approach be used in my own care to better track apathy and daily functioning?
3The trial focused heavily on real-life behaviors like going to bed, getting up, and involvement in meals — are these kinds of daily routines something my care team is already assessing, and if not, should they be?
4Because this was not a treatment trial but an observational measurement study, what does it tell us about how apathy is currently understood in frontotemporal dementia versus Alzheimer's disease, and does that distinction affect how my symptoms would be managed?
5Given that this study tracked caregiver-observed behaviors like signs of tiredness and quality of interactions during meals, how can my family or caregivers best report these kinds of changes to you so they're factored into my ongoing care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceleration (in g)

Timeframe: 28 days

Electrodermal activity (in microsiemens)

Timeframe: 28 days

Blood volume pulse (or relative blood flow)

Timeframe: 28 days

Bedtime and getting up time (Week 1)

Timeframe: once during the first week of the follow-up

Bedtime and getting up time (Week 2)

Timeframe: once during the second week of the follow-up

Bedtime and getting up time (Week 3)

Timeframe: once during the third week of the follow-up

Bedtime and getting up time (Week 4)

Timeframe: once during the fourth week of the follow-up

Trial details

NCT IDNCT04865172

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-04-18

View on ClinicalTrials.gov More Frontotemporal Dementia, Behavioral Variant trials

Plain-language summary

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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);

What they're measuring

Acceleration (in g)

Timeframe: 28 days

Electrodermal activity (in microsiemens)

Timeframe: 28 days

Blood volume pulse (or relative blood flow)

Timeframe: 28 days

Bedtime and getting up time (Week 1)

Timeframe: once during the first week of the follow-up

Bedtime and getting up time (Week 2)

Timeframe: once during the second week of the follow-up

Bedtime and getting up time (Week 3)

Timeframe: once during the third week of the follow-up

Bedtime and getting up time (Week 4)

Timeframe: once during the fourth week of the follow-up

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

ECOCAPTURE for the Assessment of Apathy Under Real-life Conditions

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria