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Ecological Assessment of Autonomy and Apathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01661660
Acronym
Dem@Care
Enrollment
126
Registered
2012-08-09
Start date
2012-06-25
Completion date
2015-12-01
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Demential Alzheimer Patient, Predemential Alzheimer Patient, Witness

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.

Interventions

Observation during a physical exercise

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
the evaluation score of autonomyIt will be evaluated at time = 0 for each patientThe 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

MeasureTime frameDescription
analyze differences between inter-group patientsIt will be evaluated at time = 0 for each patientThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026