Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research (09-PP-06)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actigraphy and video recording signal
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring alzheimer, apathy, actigraphy
Eligibility Criteria
Inclusion Criteria:
- male or female, > 65 years ;
- Alzheimer's disease according to the NINCDS-ADRDA criteria (McKhann,Drachman et al. 1984) ;
- Mini Mental Test Examination (MMSE) > 20 ;
- no motor anomaly according to UPDRS III (tremblements, rigidité musculaire) ;
- no depression criteria according to DSM IV-R criteria ;
- patient with a cholinergic treatment at dose stable since 3 months ;
- patient with social insurance ;
- signature of informed consent.
Exclusion Criteria:
- neuropsychologics assessment impossible due to sensorial and disrupt ;
- prescription of psychotrop treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week previous actigraphy recording.
Sites / Locations
- Nice University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Alzheimer and apathy
alzheimer without disease
Case control
Arm Description
Alzheimer's disease patients with apathy
Alzheimer's disease patients without apathy
subject without apathy neither Alzheimer's disease
Outcomes
Primary Outcome Measures
assessment of motricity
Secondary Outcome Measures
video recording
Full Information
NCT ID
NCT01049555
First Posted
January 12, 2010
Last Updated
September 29, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01049555
Brief Title
Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Acronym
09-PP-06
Official Title
Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 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
Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and other dementias. Irrespective of the severity of the disease, the most frequently encountered symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and psychiatric conditions. Apathy is a disorder of motivation, defined as "the direction, intensity and persistence of goal-directed behaviour". Most of the current descriptions acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour, cognition or emotion. The classical neuropsychiatric symptom assessments are subjective structured interview-based, using input from the caregiver and/or the patient. New technologies are likely to provide us with a more objective measure. An example is ambulatory actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in three dimensions.
The aim of the present study is to assess using actigraphy and video recording signal, AD patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an activity of daily living scenario .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
alzheimer, apathy, actigraphy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer and apathy
Arm Type
Other
Arm Description
Alzheimer's disease patients with apathy
Arm Title
alzheimer without disease
Arm Type
Other
Arm Description
Alzheimer's disease patients without apathy
Arm Title
Case control
Arm Type
Other
Arm Description
subject without apathy neither Alzheimer's disease
Intervention Type
Other
Intervention Name(s)
Actigraphy and video recording signal
Intervention Description
Actigraphy and video recording signal during 1 hour
Primary Outcome Measure Information:
Title
assessment of motricity
Time Frame
one time point - at the only visit of protocol
Secondary Outcome Measure Information:
Title
video recording
Time Frame
one time point - at the only visit of the protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male or female, > 65 years ;
Alzheimer's disease according to the NINCDS-ADRDA criteria (McKhann,Drachman et al. 1984) ;
Mini Mental Test Examination (MMSE) > 20 ;
no motor anomaly according to UPDRS III (tremblements, rigidité musculaire) ;
no depression criteria according to DSM IV-R criteria ;
patient with a cholinergic treatment at dose stable since 3 months ;
patient with social insurance ;
signature of informed consent.
Exclusion Criteria:
neuropsychologics assessment impossible due to sensorial and disrupt ;
prescription of psychotrop treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week previous actigraphy recording.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PU-PH
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
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