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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01384344
First received: May 27, 2011
Last updated: December 17, 2012
Last verified: May 2011
  Purpose

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".


Condition Intervention
Alzheimer Disease
Other: observational

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • stride and speed walking [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • For reproducibility, we use stride and speed walking [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
  • Reliability is the sum of posture's concordance [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]
  • Relation between LF/HF variations and activity index [ Time Frame: one time point - at the only visit of protocol (day 1) ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384344

Locations
France
Hôpital de Cimiez
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Philippe ROBERT, PU-PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01384344     History of Changes
Other Study ID Numbers: 11-PP-03
Study First Received: May 27, 2011
Last Updated: December 17, 2012
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014