Informations générales (source: ClinicalTrials.gov)
Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer (MOMAD)
Interventional
N/A
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
avril 2010
juillet 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Univserity Hospital of Besançon - Psychiatry Department - 25000 - Besançon - France | Julie MONNIN, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- subject age under 60