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Clinical Trials/NCT01661660
NCT01661660
Completed
Not Applicable

Ecological Assessment of Autonomy and Apathy in Alzheimer Patients at Mild and Moderate Stages, as Welle as in Healthy Control Particpants

Centre Hospitalier Universitaire de Nice1 site in 1 country126 target enrollmentJune 25, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Predemential Alzheimer Patient
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
126
Locations
1
Primary Endpoint
the evaluation score of autonomy
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2012
End Date
December 1, 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

the evaluation score of autonomy

Time Frame: 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 Outcomes

  • analyze differences between inter-group patients(It will be evaluated at time = 0 for each patient)

Study Sites (1)

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