Status:
COMPLETED
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Brain Institute Paris (ICM)
Pitié-Salpêtrière Hospital (AP-HP)
Conditions:
Apathy
Behavioral Variant Frontotemporal Dementia (bvFTD)
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
Apathy is defined as a quantitative reduction in voluntary and goal-directed behavior. To address this, the investigators propose an ethological approach to assess apathy objectively and quantitativel...
Detailed Description
A pilot study, ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015), was conducted with participants diagnosed with the behavioral variant of frontotemporal dementia (bvFTD) matched for age, gender, and ...
Eligibility Criteria
Inclusion
- Eligibility Criteria for All Groups:
- Demonstrates the ability to provide informed consent for participation in the study.
- Capable of understanding study instructions and performing cognitive tasks as required.
- Enrolled in a valid health insurance plan.
- Eligibility Criteria for Patients:
- Mini-Mental State Examination (MMSE): Score ≥ 17.
- Medical History: Absence of any other neurological or psychiatric conditions.
- Caregiver Requirement: Must have a caregiver present.
- Patient Groups:
- Diagnosed with behavioral variant frontotemporal dementia (bvFTD) based on the Rascovsky criteria (Rascovsky et al., 2011).
- Diagnosed with Major Depressive Disorder (MDD) according to DSM-IV criteria.
- Eligibility Criteria for Healthy Age-, Sex-, and Education-Matched Controls:
- Mini-Mental State Examination (MMSE): Score \> 27.
- Medical History: No history of neurological or psychiatric disorders.
Exclusion
- MRI Contraindications: Standard contraindications to magnetic resonance imaging (e.g., pacemaker, metallic implants, claustrophobia).
- Cognitive Barriers: Inability to comprehend study instructions.
- Legal Restrictions: Individuals referenced in Articles L.1121-5 to L.1121-8 and L.1122-12 of the French Public Health Code.
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03272230
Start Date
September 6 2017
End Date
May 8 2024
Last Update
November 29 2024
Active Locations (1)
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1
Paris Brain Institute / ICM / Pitié-Salpêtrière Hospital AP-HP / CIC
Paris, France, 75013