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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

Study Description
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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 .


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Actigraphy and video recording signal Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Alzheimer and apathy
Alzheimer's disease patients with apathy
 Other: Actigraphy and video recording signal
Actigraphy and video recording signal during 1 hour
alzheimer without disease
Alzheimer's disease patients without apathy
 Other: Actigraphy and video recording signal
Actigraphy and video recording signal during 1 hour
Case control
subject without apathy neither Alzheimer's disease
 Other: Actigraphy and video recording signal
Actigraphy and video recording signal during 1 hour


Outcome Measures
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Primary Outcome Measures :
  1. assessment of motricity [ Time Frame: one time point - at the only visit of protocol ]

Secondary Outcome Measures :
  1. video recording [ Time Frame: one time point - at the only visit of the protocol ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049555


Locations
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France
Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Philippe ROBERT, PU-PH Nice University Hospital
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01049555    
Other Study ID Numbers: 09-PP-06
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Centre Hospitalier Universitaire de Nice:
alzheimer
apathy
actigraphy
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders