Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

Alzheimer Disease Clinical Trial

Official title:

Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833274
• Other study ID #: 06-CIR-01
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: December 8, 2011
• Start date: February 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

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

• MMSE >20

Exclusion Criteria:

• Motor or psychiatric disorders

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Neurodegenerative Diseases

Intervention

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.

Locations

Country	Name	City	State
France	CM2R, Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction times (ms), using a computerized test		one time point, at day 0 (day of inclusion) during the computerized test	No
Secondary	Apathy severity, using a specific apathy scale (Apathy Inventory)		one time point, at day 0 (day of inclusion), during the visit	No