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Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00833274
First received: January 28, 2009
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Alzheimer Disease
 Behavioral: computerized test

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Reaction times (ms), using a computerized test [ Time Frame: one time point, at day 0 (day of inclusion) during the computerized test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apathy severity, using a specific apathy scale (Apathy Inventory) [ Time Frame: one time point, at day 0 (day of inclusion), during the visit ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833274

Locations
France
CM2R, Nice University Hospital
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00833274     History of Changes
Other Study ID Numbers: 06-CIR-01
Study First Received: January 28, 2009
Last Updated: December 8, 2011
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013