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Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00833274
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:

Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: computerized test Not Applicable

Detailed Description:

MATERIAL: 13 patients with Mild Cognitive Impairment (MCI), 15 patients with Alzheimer's disease (AD) and 91 elderly healthy subjects were enrolled. A computerized test using the experiment software E-prime® was designed to assess reaction times (in ms) in different experimental conditions after a training trial (neutral, stimulation, stress, stimulation after stress, extinction) and relation between the performances to the test and the Apathy Inventory (AI) scores (lack of initiative, lack of interest, emotional blunting) were observed.

METHOD: Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white. After pressing the button, a randomized colorized geometric figure appears on the screen, and disappears automatically after a few seconds, replaced by a new white screen. Reaction time (in ms) between a white screen and a press of the button is analysed. After a training trial, reaction times are analysed in different experimental conditions: neutral - stimulation1 (patient gets points when pressing the button) - stress (alarm) - stimulation2 (patient gets points when pressing, after the stress trial) - extinction (similar to neutral condition).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
Study Start Date : February 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white.
 Behavioral: computerized test
Using a computerized test, each patient is asked to press a button (mouse of the computer) each time the screen of the computer becomes completely white.


Outcome Measures
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Primary Outcome Measures :
  1. Reaction times (ms), using a computerized test [ Time Frame: one time point, at day 0 (day of inclusion) during the computerized test ]

Secondary Outcome Measures :
  1. Apathy severity, using a specific apathy scale (Apathy Inventory) [ Time Frame: one time point, at day 0 (day of inclusion), during the visit ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elderly patients with diagnosis of Alzheimer's Disease according to DSM-IV criteria
  • MMSE >20

Exclusion Criteria:

  • None
  • Motor or psychiatric disorders
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): NCT00833274


Locations
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France
CM2R, Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00833274    
Other Study ID Numbers: 06-CIR-01
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders