Ecological Assessment of Autonomy and Apathy

Witness Clinical Trial

— Dem@Care  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661660
• Other study ID #: 12-PP-01
• Status: Completed
• Phase: N/A
• Start date: June 25, 2012
• Est. completion date: December 1, 2015

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Subjects control Inclusion criteria

• Male or Female = 65 years

• Subjects were not accompanied by an Alzheimer subject recruited for the study;

• Subjects showing no locomotor disability;

• Subjects with no cognitive impairment overall with a score> 27 on the MMSE.

Special cases:

people with no schooling aged 50 to 79 years we take a MMSE> 22/30 and for over 80 years a MMSE> 21/30 - by the standards of Kalafat, 2003) (Folstein, Folstein et al. 1975), or arguments in favor of the following diagnosis: probable Alzheimer's disease according to the criteria of the NINCDS-ADRDA and / or major depressive episode according to DSM-IV-R;

• Subjects receiving a social security system;

• Signature of informed consent.

Exclusion Criteria

• Failure to perform the protocol due to a mobility impairment;

• Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;

• Patients implanted with a pacemaker;

• Patient Trust under curatorship or judicial protection;

• Detainees (administrative or judicial).

Predementia / MCI Patients Inclusion criteria

• Men or women = 65 years.

• Subjects with a diagnosis of MCI according to the criteria of the National Institute on Ageing and Alzheimer's Association group (Albert MS, 2011, see Appendix B), or Alzheimer's disease stage prédementiel (B. Dubois, 2010; see Appendix C)

• Subjects with a score of 0 to items of "tremors" and "muscle stiffness" of the UPDRS III

• Subjects with no criteria for major depressive episode according to DSM IV-R;

• Subjects receiving a social security system;

• Signature of informed consent. Exclusion Criteria

• Failure to pass neuropsychological testing because of a sensory or motor deficit;

• Prescription of a new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;

• Patients implanted with a pacemaker;

• Patient Trust under curatorship or judicial protection.

dementia subjects Inclusion criteria

• Men and women older than 65 years

• Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or Alzheimer's typical or atypical (B. Dubois et al. 2007)

• MMSE score = 16

• Subjects with a score of 0 to items of "tremors" and "muscle stiffness" of the UPDRS III

• Subjects with no criteria for major depressive episode according to DSM IV-R;

• Subjects receiving drug treatment by acetylcholinesterase inhibitor or memantine in standard dose and stable for at least 3 months;

• Subjects receiving a social security system;

• Signature of informed consent.

Exclusion Criteria

• Failure to pass neuropsychological testing because of a sensory or motor deficit;

• Prescription of psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment;

• Patients implanted with a pacemaker

• Patient Trust under curatorship or judicial protection.

Related Conditions & MeSH terms

• Demential Alzheimer Patient
• Predemential Alzheimer Patient
• Witness

Intervention

Other:
• observationnal
Observation during a physical exercise

Locations

Country	Name	City	State
France	CHU de Nice- Hôpital Cimiez_ CMRR	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the evaluation score of autonomy	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	It will be evaluated at time = 0 for each patient
Secondary	analyze differences between inter-group patients	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.	It will be evaluated at time = 0 for each patient