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Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computerized test
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  • Motor or psychiatric disorders

Sites / Locations

  • CM2R, Nice University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Reaction times (ms), using a computerized test

Secondary Outcome Measures

Apathy severity, using a specific apathy scale (Apathy Inventory)

Full Information

First Posted
January 28, 2009
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00833274
Brief Title
Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
Official Title
Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
computerized test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reaction times (ms), using a computerized test
Time Frame
one time point, at day 0 (day of inclusion) during the computerized test
Secondary Outcome Measure Information:
Title
Apathy severity, using a specific apathy scale (Apathy Inventory)
Time Frame
one time point, at day 0 (day of inclusion), during the visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CM2R, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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