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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01049555
First received: January 12, 2010
Last updated: September 29, 2015
Last verified: September 2015
  Purpose

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 Intervention
Alzheimer's Disease
Other: Actigraphy and video recording signal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research

Resource links provided by NLM:


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

Primary Outcome Measures:
  • assessment of motricity [ Time Frame: one time point - at the only visit of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • video recording [ Time Frame: one time point - at the only visit of the protocol ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01049555

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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01049555     History of Changes
Other Study ID Numbers: 09-PP-06 
Study First Received: January 12, 2010
Last Updated: September 29, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
alzheimer
apathy
actigraphy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 27, 2016