Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
observational
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility 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
Sites / Locations
- Hôpital de Cimiez
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
witness
Alzheimer disease with apathy
Alzheimer's disease without apathy
Arm Description
no mnesic complaint
Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy
Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy
Outcomes
Primary Outcome Measures
stride and speed walking
Secondary Outcome Measures
For comparison between Alzheimer disease patients with (n=20) or without apathy, we use again stride and speed walking
For reproducibility, we use stride and speed walking
Reliability is the sum of posture's concordance
Relation between LF/HF variations and activity index
Full Information
NCT ID
NCT01384344
First Posted
May 27, 2011
Last Updated
December 17, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01384344
Brief Title
Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy
Official Title
Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
witness
Arm Type
Active Comparator
Arm Description
no mnesic complaint
Arm Title
Alzheimer disease with apathy
Arm Type
Experimental
Arm Description
Alzheimer's disease according to criteria of NINCDS-ADRDA with apathy
Arm Title
Alzheimer's disease without apathy
Arm Type
Experimental
Arm Description
Alzheimer's disease according to criteria of NINCDS-ADRDA without apathy
Intervention Type
Other
Intervention Name(s)
observational
Intervention Description
Observation during a physical exercise
Primary Outcome Measure Information:
Title
stride and speed walking
Time Frame
one time point - at the only visit of protocol (day 1)
Secondary Outcome Measure Information:
Title
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)
Title
For reproducibility, we use stride and speed walking
Time Frame
one time point - at the only visit of protocol (day 1)
Title
Reliability is the sum of posture's concordance
Time Frame
one time point - at the only visit of protocol (day 1)
Title
Relation between LF/HF variations and activity index
Time Frame
one time point - at the only visit of protocol (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PU-PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de Cimiez
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
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Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Video Recognition and Actigraphy
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