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Eye Movement Recording as an Early Differential Diagnostic Tool for Alzheimer/Depression (MOMAD)

Primary Purpose

Alzheimer Disease, Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer disease, Depression, Differential diagnosis, Eye movement

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • subject whose visual acuity > 9/10
  • subject without a diagnosis of eye disease
  • subject without a neuropsychological sequelae
  • for depressed patients :subject with a diagnosis of depression confirmed by a psychiatric evaluation and MADRS (Montgomery and Asberg Depression Rating Scale) score >25 and without cognitive impairment or any other psychiatric pathology and MMSE (Mini Mental State Examination)≥18 and without symptoms of AD
  • for Alzheimer patients :subject with AD diagnosed according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke -Alzheimer's Disease and Related Disorders Association) criteria and MMSE ≥18 and without psychiatric disorder and MADRS score < 25
  • for control patients : subject without AD, depression or any other psychiatric condition identified by the diagnostic criteria or cognitive disorders and MADRS score <25 and MMSE > 20

Exclusion Criteria:

  • subject age under 60

Sites / Locations

  • Univserity Hospital of Besançon - Psychiatry DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alzheimer

Depression

Healthy

Arm Description

Patients suffering of Alzheimer disease

Patients suffering from depression

Healthy volunteers

Outcomes

Primary Outcome Measures

pro-saccade task
The score differences to pro-saccade task between the 3 groups constitute the major research outcome measure used to measure the basic dynamic eye movements.
anti-saccade task
The score differences to anti-saccade task between the 3 groups consitute one of the major research outcome measure used to measure the basic dynamic eye movements.
predictive saccade task
The score differences to predictive saccade tasks between the 3 groups constitute one of the major research outcome measure used to measure the basic dynamic eye movements
scan of images pair with emotional connotation
The score differences of scan of images pair with emotional connotation were used to evaluate the emotional tasks
portrait analysis
The score differences of portrait analysis were used to evaluate the emotional tasks

Secondary Outcome Measures

Full Information

First Posted
September 14, 2011
Last Updated
July 27, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Laboratoire de psychologie EA 3188, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Novillars
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1. Study Identification

Unique Protocol Identification Number
NCT01434940
Brief Title
Eye Movement Recording as an Early Differential Diagnostic Tool for Alzheimer/Depression
Acronym
MOMAD
Official Title
Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Laboratoire de psychologie EA 3188, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Novillars

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The global aim of our study is to validate eye movement recording as an early differential diagnostic tool, in order to discriminate as early as possible between neurodegenerative dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD respectively. Eye movements are sensitive markers of neurological diseases and can be used in a variety of clinical neurological syndromes. This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy persons. The patients AD will be recruited in the Memory Centre of Resources and Research of Besançon and patients DPD will be selected in the psychiatric department of the University Hospital of Besançon. The control participants will be recruited from the entourage of researchers and patients. The selection of participants in the 3 different groups is based on clinical examinations in psychiatry and neurology and neuropsychological assessments. After giving informed consent, patients will be evaluated by a psychiatrist and a neuropsychologist. The complete assessment takes 150 minutes. After having set up patients, eye movements will be recorded using video-oculography techniques. The following tasks are performed: the basic dynamic eye movements (latency, hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter) will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The emotional connotation tasks will be assessed by scan of images pair with emotional connotation and portrait analysis. The assessment takes 30 minutes. This study will include 3 groups: an Alzheimer group; a depressed group; a control group with healthy persons. The population of this study will be comprised of patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and not neuropsychological sequelae that could disrupt the functioning oculomotor. These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Depression
Keywords
Alzheimer disease, Depression, Differential diagnosis, Eye movement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer
Arm Type
Experimental
Arm Description
Patients suffering of Alzheimer disease
Arm Title
Depression
Arm Type
Experimental
Arm Description
Patients suffering from depression
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Other
Intervention Name(s)
Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
Intervention Description
. The system named H6-HSCN by Applied Science Laboratories (ASL®) helps keep the patient's head fixed on a support, important for the elderly population. This system allows to capture data with good temporal resolution (sampling at 360Hz) and good spatial resolution (accuracy of 0.1° of visual angle) at a distance of about 70 cm from the screen test with a visual angle of 32.6°. Results will be processed with ASL Result Software.
Primary Outcome Measure Information:
Title
pro-saccade task
Description
The score differences to pro-saccade task between the 3 groups constitute the major research outcome measure used to measure the basic dynamic eye movements.
Time Frame
session1: after psychiatric and neuropsychologic assessment
Title
anti-saccade task
Description
The score differences to anti-saccade task between the 3 groups consitute one of the major research outcome measure used to measure the basic dynamic eye movements.
Time Frame
session 2: after session 1 (pro-saccade task)
Title
predictive saccade task
Description
The score differences to predictive saccade tasks between the 3 groups constitute one of the major research outcome measure used to measure the basic dynamic eye movements
Time Frame
session 3: after session 2 (anti-saccade task)
Title
scan of images pair with emotional connotation
Description
The score differences of scan of images pair with emotional connotation were used to evaluate the emotional tasks
Time Frame
session 4 : after session 3 (predictive saccade task)
Title
portrait analysis
Description
The score differences of portrait analysis were used to evaluate the emotional tasks
Time Frame
session 5: after session 4 (scan of images pair with emotional connotation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: subject whose visual acuity > 9/10 subject without a diagnosis of eye disease subject without a neuropsychological sequelae for depressed patients :subject with a diagnosis of depression confirmed by a psychiatric evaluation and MADRS (Montgomery and Asberg Depression Rating Scale) score >25 and without cognitive impairment or any other psychiatric pathology and MMSE (Mini Mental State Examination)≥18 and without symptoms of AD for Alzheimer patients :subject with AD diagnosed according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke -Alzheimer's Disease and Related Disorders Association) criteria and MMSE ≥18 and without psychiatric disorder and MADRS score < 25 for control patients : subject without AD, depression or any other psychiatric condition identified by the diagnostic criteria or cognitive disorders and MADRS score <25 and MMSE > 20 Exclusion Criteria: subject age under 60
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre VANDEL, Prof
Phone
+33381218073
Email
pierre.vandel@univ-fcomte.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre VANDEL, Prof
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univserity Hospital of Besançon - Psychiatry Department
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie MONNIN, PhD
Phone
+33381218543
Email
jmonnin@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Magali NICOLIER, PhD
Phone
+3381218073
Email
mnicolier@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Pierre VANDEL, PUPH

12. IPD Sharing Statement

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Eye Movement Recording as an Early Differential Diagnostic Tool for Alzheimer/Depression

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