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

September 29, 2015 updated by: Centre Hospitalier Universitaire de Nice

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assessment of motricity
Time Frame: one time point - at the only visit of protocol
one time point - at the only visit of protocol

Secondary Outcome Measures

Outcome Measure
Time Frame
video recording
Time Frame: one time point - at the only visit of the protocol
one time point - at the only visit of the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-PP-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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