Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Variability of reflexive saccades latencies
研究概览
简要总结
The aim of this study is to determine whether saccadic eye movement recording may help in the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the disease.
Study type: Interventional Study design: Intervention Model: Single group assignment Primary purpose: Diagnostic
详细描述
Dementia with Lewy bodies (DLB) is the second most common cause of neurodegenerative dementia. In its early stages, the differential diagnosis of DLB and Alzheimer's disease (AD) can be challenging. The differential diagnosis is particularly important given that patients with DLB respond well to cholinesterase inhibitors but show sensitivity to neuroleptic medications which are contraindicated in DLB. DLB tends to progress more quickly than Alzheimer's disease. Diagnostic accuracy may be improved. Oculomotor recording, easy to perform could be helpful in order to identify and reliably assess fluctuating attention performance in DLB patients.
Main objective:
- to improve differential diagnosis between DLB and AD in the early stages of the disease with oculomotor measurements
Secondary objectives:
- to examine the association between the oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
- to evaluate the benefit of complementary neuropsychological tests in the distinction between DLB and AD cases
- to examine the relationship between hippocampal volume and neuropsychological examination in DLB cases
- to examine the diagnostic performance of MRI (Support Vector Machine) between DLB and AD
- to examine the interest of CSF alpha synuclein concentration to discriminate DLB from AD
- to assess at one year variations in oculomotor test scores and neuropsychological test scores Method and design Longitudinal multicenter study including 100 patients with a DLB or AD diagnosis. Clinical examination at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 and over
- •Patients with a diagnosis of probable DLB or AD according to the Consortium on DLB criteria (McKeith et al 2005) for Lewy bodies dementia and according to DSM IV and NINCDS- ADRDA criteria for AD or patients in whom there is diagnostic uncertainty between DLB and AD
- •No major sensory deficits
- •MMSE > 20
- •Having signed an informed consent form
排除标准
- •Parkinson syndrome progressing for more than one year regarding cognitive impairment
- •Use of AchEIs medication
- •Taking or having taken anti Parkinson drugs
- •Neuroleptic drugs over the previous three months
- •Contraindication for lumbar puncture (i.e. anticoagulant agents)
- •Patients with Geriatric Depression Scale (GDS) > 10
- •Taking medication that could impact dopamine transporter's measurement
- •Contraindication for MRI examination
- •Diseases involving the short-term survival (shorter than one year)
- •Not fluent in French
- •Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
- •Being under guardianship
- •Absence of caregiver/informant to sign informed consent form
- •Non health insurance affiliation
研究组 & 干预措施
Early stage of dementia
oculomotor measurements
干预措施: oculomotor measurements (Other)
结局指标
主要结局
Variability of reflexive saccades latencies
时间窗: at one year
The variability is indicated by the coefficient of variation (i.e. standard-error/mean) of saccades latencies in the gap paradigm. The variability and mean latency are expected to be increased while the percentage of express latencies decreased in DLB patients
次要结局
- Correlations between oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations(at one year)
- Potential correlations between hippocampal volume and neuropsychological examination in DLB cases(at one year)
- Cerebral atrophy differences between DLB and AD using SVM (Support Vector Machine) method(at one year)
- Percentage of alpha synuclein in CSF to discriminate DLB from AD(at one year)
- Variations at one year in oculomotor test scores and neuropsychological test scores(at one year)
- Mean reflexive saccades latency(at one year)
- Percentage of express saccades(at one year)
- Correlations between neuropsychological tests scores assessing attention abilities and variability of reflexive saccades latencies(at one year)