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

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

Tracking Information

• First Submitted Date: January 12, 2010
• First Posted Date: January 14, 2010
• Last Update Posted Date: September 30, 2015
• Study Start Date: September 2011
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 13, 2010): assessment of motricity [ Time Frame: one time point - at the only visit of protocol ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 13, 2010): video recording [ Time Frame: one time point - at the only visit of the protocol ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Alzheimer's Disease

Intervention

Other: Actigraphy and video recording signal

Actigraphy and video recording signal during 1 hour

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2015): 42
• Original Estimated Enrollment (submitted: January 13, 2010): 35
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01049555
• Other Study ID Numbers: 09-PP-06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Centre Hospitalier Universitaire de Nice
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Philippe ROBERT, PU-PH; Nice University Hospital

• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: September 2015