NCT00833274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

Enrollment Period

2.7 years

First QC Date

January 28, 2009

Last Update Submit

December 8, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reaction times (ms), using a computerized test

    one time point, at day 0 (day of inclusion) during the computerized test

Secondary Outcomes (1)

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

    one time point, at day 0 (day of inclusion), during the visit

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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.

1

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None
  • Motor or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CM2R, Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2009

First Posted

February 2, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations