NCT01661660: Dem@Care

Ecological Assessment of Autonomy and Apathy

Completed NA Last updated 13 November 2023

What this trial tests

NA trial testing observationnal in Predemential Alzheimer Patient in 126 participants. Completed in 1 December 2015.

Timeline

25 June 2012

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	126
Start date	25 June 2012
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across France

Drugs / interventions tested

• observationnal

Conditions studied

• Predemential Alzheimer Patient — all drugs for Predemential Alzheimer Patient →
• Demential Alzheimer Patient — all drugs for Demential Alzheimer Patient →
• Witness — all drugs for Witness →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

65 and older, any sex, with Predemential Alzheimer Patient or Demential Alzheimer Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.