Ecological Assessment of Autonomy and Apathy

NCT01661660 | Completed

• 1 other identifier: 12-PP-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Predemential Alzheimer Patient; Demential Alzheimer Patient; Witness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• analyze differences between inter-group patients

  It will be evaluated at time = 0 for each patient

Study Arms (3)

Control subjects

ACTIVE COMPARATOR

Control subjects were people with memory complaints coming for a consultation and prevention.

Other: observationnal

Predementia / MCI patients

EXPERIMENTAL

Subjects at predementia stage or MCI stage

Other: observationnal

Dementia patient

EXPERIMENTAL

Subjects at demential stage

Other: observationnal

Interventions

observationnal OTHER

Observation during a physical exercise

Control subjects; Dementia patient; Predementia / MCI patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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;
• 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.
• Men and women older than 65 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice- Hôpital Cimiez_ CMRR

Nice, 06000, France

Location

Study Officials

• Philippe ROBERT, PU-PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: August 9, 2012
• Study Start: June 25, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

FR (1)