Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy

December 17, 2012 updated by: Centre Hospitalier Universitaire de Nice

Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy

Cognitive and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. These symptoms are noticed before the diagnostic of dementia, their prevalence and their intensity increase with the evolution of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of cognition and behaviour to "go in goal". Assessment of psychological and behavioural symptoms is realised principally with neuropsychiatric scales. These contribute to obtain particular informations about health of patient allowing by patient and caregiver discussions and impressions of clinician. These scales are simples but loss of subjectivity. An alternative of this method is the use of gerontechnology as actigraphy (system out-patient which records locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video recording which is associated to an informatic treatment of signal in order event recognition.

The aim of study is to realise an objective assessment of activities "go in goal" during experimental sequence which has well-characterized acts, using at the same time an actigraphic record of activity "motive" (system of assessment indirect of apathy fit) and a video records which uses an informatic event recognition system. The assessment will realise with participants controls (n=30) and Alzheimer disease patients with (n=20) or without (n=20) apathy, during well-characterized records. The final aim is to obtain a particular assessment of some disorders behaviours, as apathy, which is principally characterize by a decrease of behaviours "to go in goal".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Hôpital de Cimiez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for no mnesic patient:

  • man or female, more 65 years ;
  • no caregiver ;
  • no motor handicap ;
  • no global cognitive impairment with > 26 MMSE, neither argument in favour of following diagnosis : Alzheimer's disease, major depressive episode ;
  • no apathy ;
  • participant with french national health ;
  • signature of informed consent.

Inclusion Criteria for Alzheimer's patient:

  • man or female, more 65 years ;
  • no motor handicap ;
  • with diagnosis of Alzheimer's disease according to criteria of NINCDS-ADRDA ;
  • apathy score > 3 in Neuropsychiatric Inventory ;
  • with a MMSE score lower than 26/30 ;
  • with cholinesterase inhibitor medication, standard and stable dose since 3 month ;
  • no global cognitive impairment with > 26 MMSE, neither argument in favour of following diagnosis : Alzheimer's disease, major depressive episode ;
  • no apathy ;
  • participant with french national health ;
  • signature of informed consent.

Exclusion Criteria:

  • Impossibility of realization of the experimental protocol because of a driving handicap.
  • Port(Bearing) of a pacemaker
  • Under guardianship Patient or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: witness
no mnesic complaint
Other: observational
Observation during a physical exercise
EXPERIMENTAL: Alzheimer disease with apathy
Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy
Other: observational
Observation during a physical exercise
EXPERIMENTAL: Alzheimer's disease without apathy
Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy
Other: observational
Observation during a physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stride and speed walking
Time Frame: one time point - at the only visit of protocol (day 1)
one time point - at the only visit of protocol (day 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
For comparison between Alzheimer disease patients with (n=20) or without apathy, we use again stride and speed walking
Time Frame: one time point - at the only visit of protocol (day 1)
one time point - at the only visit of protocol (day 1)
For reproducibility, we use stride and speed walking
Time Frame: one time point - at the only visit of protocol (day 1)
one time point - at the only visit of protocol (day 1)
Reliability is the sum of posture's concordance
Time Frame: one time point - at the only visit of protocol (day 1)
one time point - at the only visit of protocol (day 1)
Relation between LF/HF variations and activity index
Time Frame: one time point - at the only visit of protocol (day 1)
one time point - at the only visit of protocol (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Philippe ROBERT, PU-PH, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (ESTIMATE)

June 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-PP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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