Depression Clinical Trial
— MOMADOfficial 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.
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.
Status | Recruiting |
Enrollment | 288 |
Est. completion date | July 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Univserity Hospital of Besançon - Psychiatry Department | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon | Centre Hospitalier de Novillars, Centre Hospitalier Universitaire Dijon, Laboratoire de psychologie EA 3188 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | session1: after psychiatric and neuropsychologic assessment | |
Primary | 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. | session 2: after session 1 (pro-saccade task) | |
Primary | 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 | session 3: after session 2 (anti-saccade task) | |
Primary | 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 | session 4 : after session 3 (predictive saccade task) | |
Primary | portrait analysis | The score differences of portrait analysis were used to evaluate the emotional tasks | session 5: after session 4 (scan of images pair with emotional connotation) |
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