Alzheimer DiseaseMOMADNCT01434940
Eye Movement Recording as an Early Differential Diagnostic Tool for Alzheimer/Depression
A study testing Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam in people with Alzheimer Disease and Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Depression
- What is being tested?
- Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- subject age under 60
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Univserity Hospital of Besançon - Psychiatry Department
Besançon, 25000
Julie MONNIN, PhD, +33381218543, jmonnin@chu-besancon.fr
Magali NICOLIER, PhD, +3381218073, mnicolier@chu-besancon.fr
About this study
Official title: Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer
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.
Read more
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.
- Conditions
- Alzheimer Disease, Depression
- Being tested
- Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
- Keywords
- Alzheimer disease, Depression, Differential diagnosis, Eye movement
- Medical subject headings
- Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beamOther
. 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.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer | Experimental | Patients suffering of Alzheimer disease Receives: Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam |
| Depression | Experimental | Patients suffering from depression Receives: Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam |
| Healthy | Experimental | Healthy volunteers Receives: Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: session1: after psychiatric and neuropsychologic assessment
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.
Measured: session 2: after session 1 (pro-saccade task)
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
Measured: session 3: after session 2 (anti-saccade task)
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
Measured: session 4 : after session 3 (predictive saccade task)
portrait analysis
The score differences of portrait analysis were used to evaluate the emotional tasks
Measured: session 5: after session 4 (scan of images pair with emotional connotation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startApr 2010
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de psychologie EA 3188, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Novillars
- Responsible party
- Sponsor
- Investigators
- Pierre VANDEL, Prof, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434940
- Sponsor's protocol ID
- N/2009/55
- Acronym
- MOMAD
- Status last verified
- Jul 2017
- First submitted
- 14 Sep 2011
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer
- ClinicalTrials.gov ID
- NCT01434940
- Acronym / sponsor ID
- MOMAD / N/2009/55
- Conditions
- Alzheimer Disease, Depression
- Keywords
- Alzheimer disease, Depression, Differential diagnosis, Eye movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Laboratoire de psychologie EA 3188, Centre Hospitalier Universitaire Dijon, Centre Hospitalier de Novillars
- Study start
- Apr 2010
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer | Experimental | Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beamPatients suffering of Alzheimer disease |
| Depression | Experimental | Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beamPatients suffering from depression |
| Healthy | Experimental | Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beamHealthy volunteers |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- subject age under 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Alzheimer, Depression, Healthy |
Primary outcome
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.
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.
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre VANDEL, Prof principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam in people with Alzheimer Disease and Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre VANDEL, Prof (+33381218073, pierre.vandel@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pro-saccade task (time frame: session1: after psychiatric and neuropsychologic assessment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.