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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01049555
First received: January 12, 2010
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 35
Study Start Date: September 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049555

Contacts
Contact: Renaud DAVID, PhD 0492034278 david.r@chu-nice.fr
Contact: Julie PIANO 0492034775 piano.j@chu-nice.fr

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

No publications provided

Responsible Party: Departement de la Recherche Clinique et de l'Innovation, 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: October 20, 2010
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013