Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer
试验速览
- 阶段
- 不适用
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- predictive saccade task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •subject age under 60
研究组 & 干预措施
Alzheimer
Patients suffering of Alzheimer disease
干预措施: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam (Other)
Depression
Patients suffering from depression
干预措施: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam (Other)
Healthy
Healthy volunteers
干预措施: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam (Other)
结局指标
主要结局
predictive saccade task
时间窗: 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
pro-saccade task
时间窗: 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
时间窗: 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.
portrait analysis
时间窗: 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
scan of images pair with emotional connotation
时间窗: 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
次要结局
未报告次要终点