Capturing Apathy in Everyday Life for Dementia Patients

ECOCAPTURE@HOME: Program for the Assessment of Behavioural Markers of Apathy Under Real-life Conditions Aimed At Patients with Neurodegenerative Dementias and Their Caregivers

This study is testing whether wearable sensors can help track signs of apathy in people with dementia to improve their care and support.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Paris)
• Trial ID: NCT04865172 on ClinicalTrials.gov

What this trial studies

ECOCAPTURE@HOME aims to assess the behavioral signature of apathy in patients with frontotemporal dementia and Alzheimer's disease through remote monitoring. The study involves 60 patient-caregiver dyads who will wear multi-sensor bracelets for 28 days to collect both passive physiological data and active behavioral data via caregiver questionnaires. This innovative approach seeks to validate behavioral markers of apathy, including daytime activity, sleep quality, and emotional arousal, to enhance understanding and management of apathy in dementia. The ultimate goal is to develop a clinical tool for ongoing remote assessment of patient-caregiver dynamics.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40 to 85 diagnosed with behavioral variant frontotemporal dementia or Alzheimer's disease, along with their caregiver partners.

Not a fit: Patients with severe cognitive impairment, other cerebral pathologies, or significant psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management of apathy in dementia patients, enhancing the quality of life for both patients and caregivers.

How similar studies have performed: While the approach of remote monitoring for behavioral assessment is gaining traction, this specific methodology for capturing apathy in dementia is relatively novel and has not been extensively tested.

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

Where this trial is running

Paris

• ICM, Hôpital Salpêtrière — Paris, France (Recruiting)

Study contacts

• Principal investigator: Richard Levy, MD, PhD — Institut National de la Santé Et de la Recherche Médicale, France
• Study coordinator: Richard Levy, MD, PhD

Conditions Frontotemporal Dementia, Behavioral Variant; Alzheimer Disease