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

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ClinicalTrials.gov Identifier: NCT01434940
Recruitment Status : Unknown
Verified July 2017 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : September 15, 2011
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
Laboratoire de psychologie EA 3188
Centre Hospitalier Universitaire Dijon
Centre Hospitalier de Novillars
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Depression Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer
Study Start Date : April 2010
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Alzheimer
Patients suffering of Alzheimer disease
 Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. 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.
Experimental: Depression
Patients suffering from depression
 Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. 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.
Experimental: Healthy
Healthy volunteers
 Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. 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.


Outcome Measures
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Primary Outcome Measures :
  1. pro-saccade task [ Time Frame: session1: after psychiatric and neuropsychologic assessment ]
    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.

  2. anti-saccade task [ Time Frame: session 2: after session 1 (pro-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.

  3. predictive saccade task [ Time Frame: session 3: after session 2 (anti-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

  4. scan of images pair with emotional connotation [ Time Frame: session 4 : after session 3 (predictive saccade task) ]
    The score differences of scan of images pair with emotional connotation were used to evaluate the emotional tasks

  5. portrait analysis [ Time Frame: session 5: after session 4 (scan of images pair with emotional connotation) ]
    The score differences of portrait analysis were used to evaluate the emotional tasks


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434940


Contacts
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Contact: Pierre VANDEL, Prof +33381218073 pierre.vandel@univ-fcomte.fr

Locations
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France
Univserity Hospital of Besançon - Psychiatry Department Recruiting
Besançon, France, 25000
Contact: Julie MONNIN, PhD    +33381218543    jmonnin@chu-besancon.fr   
Contact: Magali NICOLIER, PhD    +3381218073    mnicolier@chu-besancon.fr   
Principal Investigator: Pierre VANDEL, PUPH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Laboratoire de psychologie EA 3188
Centre Hospitalier Universitaire Dijon
Centre Hospitalier de Novillars
Investigators
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Principal Investigator: Pierre VANDEL, Prof Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01434940    
Other Study ID Numbers: N/2009/55
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Alzheimer disease
Depression
Differential diagnosis
Eye movement
Additional relevant MeSH terms:
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Alzheimer Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dementia
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders