- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833274
Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06000
- CM2R, Nice University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elderly patients with diagnosis of Alzheimer's Disease according to DSM-IV criteria
- MMSE >20
Exclusion Criteria:
- None
- Motor or psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reaction times (ms), using a computerized test
Time Frame: one time point, at day 0 (day of inclusion) during the computerized test
|
one time point, at day 0 (day of inclusion) during the computerized test
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Apathy severity, using a specific apathy scale (Apathy Inventory)
Time Frame: one time point, at day 0 (day of inclusion), during the visit
|
one time point, at day 0 (day of inclusion), during the visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-CIR-01
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