Ecological Assessment of Autonomy and Apathy

Not Applicable

Completed

• Conditions: Demential Alzheimer Patient; Predemential Alzheimer Patient; Witness
• Interventions: Other: observationnal

• Registration Number: NCT01661660
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Cognitive symptoms are the core feature of Alzheimer's disease. Besides these problems, behavioural and psychological symptoms (BPSD), and an impairment of activities of daily living (IADL) are frequently encountered and usually show an impact on autonomy maintenance, prognostic and care during the prodromal and early stages of the disease.

Such symptoms are noticeable before the diagnosis of dementia and their occurrences as well as their intensity increase with the evolution of the disease.

Apathy, initially defined as a reduction of motivated behaviours, is the most frequently observed BPSD. Apathy is clinically defined by a significant reduction or complete loss of interest, initiative capacity and emotional blunting. Accordingly, apathy is characterized by diminished goal-directed cognitions and behaviours.

Behavioural and psychological assessment relies essentially on neuropsychiatric scales. These are used to gather precise data regarding patient's clinical state from interviews with the patient, the career or from clinical impressions during the consultation. From their apparent simplicity they have made their way into daily clinical practices, yet neuropsychiatric scales are reportedly biased by the assessors' subjectivity.

However, some tools whose allow simple, fast and objectively valid assessments are not widely used.

Hence, the use of ICT such as actigraphy (wearable device assessing locomotion activities), automatized audio-video recognition and signal analysis from events, may be of interest in addition to current assessment methods.

The aim of this study is to implement an objective assessment of goal directed activities and autonomy in an experimental design including predefined actions. The setting includes video cameras, microphones, actigraphic and Galvanic Skin Response sensors for recording and computer-based recognition of events using audio-video data, locomotion data and sinusal variability respectively as well as extracting biomarkers for supporting detection of dementia at early stages and supporting ongoing tracking of the dementia disease state. The following population will be included: patients with Mild Cognitive Impairment (n=50), patients with Alzheimer's disease (n=50) and control participants (n=50).

This work will provide further objective information for clinical practitioner in order to detect behavioral disturbances such as apathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-25
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Primary Completion: 2015-12-01
• Study Completion: 2015-12-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dementia patient	observationnal	Subjects at demential stage
Predementia / MCI patients	observationnal	Subjects at predementia stage or MCI stage
Control subjects	observationnal	Control subjects were people with memory complaints coming for a consultation and prevention.

Primary Outcome Measures

Name	Time	Method
the evaluation score of autonomy	It will be evaluated at time = 0 for each patient	The primary outcome used to differentiate patients with Alzheimer's disease in pre-demented control subjects is the evaluation score of autonomy calculated from data collected during the execution of step semi directed

Secondary Outcome Measures

Name	Time	Method
analyze differences between inter-group patients	It will be evaluated at time = 0 for each patient	The impact of behavioral problems in activities of daily living will be evaluated using the same criteria for evaluating the main objective analysis by an international group in a category between subjects diagnosed patients apathetic and not apathetic. Actigraphy data, recorded from the ecological assessment in experiment room until the end of the final medical examination, will quantify and qualify the motor activity of the subject at its presence on the premises of CMRR to compare these measures during the evaluation phases in experiment room, consulting and outside these two periods.

Trial Locations

Locations (1)

CHU de Nice- Hôpital Cimiez_ CMRR; 🇫🇷 Nice, France