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Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research (09-PP-06)

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ClinicalTrials.gov Identifier: NCT01049555
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 14, 2010
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
assessment of motricity [ Time Frame: one time point - at the only visit of protocol ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
video recording [ Time Frame: one time point - at the only visit of the protocol ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Official Title  ICMJE Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
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 .

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Other: Actigraphy and video recording signal
Actigraphy and video recording signal during 1 hour
Study Arms  ICMJE
  • Alzheimer and apathy
    Alzheimer's disease patients with apathy
    Intervention: Other: Actigraphy and video recording signal
  • alzheimer without disease
    Alzheimer's disease patients without apathy
    Intervention: Other: Actigraphy and video recording signal
  • Case control
    subject without apathy neither Alzheimer's disease
    Intervention: Other: Actigraphy and video recording signal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2010)
35
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049555
Other Study ID Numbers  ICMJE 09-PP-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Nice
Original Responsible Party Departement de la Recherche Clinique et de l'Innovation, CENTRE HOSPITALIER UNIVERSITAIRE DE NICE
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe ROBERT, PU-PH Nice University Hospital
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP