" The Eyes Have it " : Ocular Saccade Abnormalities in Prodromal Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- Saccades execution parameters
研究概览
简要总结
Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •All patient groups:
- •Age >60 years
- •Normal vision work-up : (corrected binocular visual acuity > 8/10)
- •Written informed consent
- •Subjects affiliated to Social Security
- •Group A: Prodromal AD.
- •Memory complaints.
- •Normal or slight restriction of IADL.
- •"hippocampal-type" amnesic syndrome defined by poor free recall despite adequate (and controlled) encoding, decreased total recall because of insufficient effect of cuing or impaired recognition, numerous intrusions (RL/RI-16items)
- •CDR (Clinical Dementia Rating Scale) ≥ 0,5
- •Persistence of memory changes at a subsequent assessment (>3 months)
- •Absence of global cognitive deterioration (MMSE ≥24)
- •Exclusion of other disorders that may cause mild cognitive impairment with adequate tests
- •1.5 Tesla diagnosis MRI with at least T2, Flair transversal sections and coronal T1 sections in the coronal plan. Absent or slight medio temporal/hippocampal atrophy or if available (non mandatory) characteristic CSF betaA42/tau ratio
- •Group B: Typical AD (mild to moderate)
- •NINDS-ADRDA diagnosis criteria
- •MMSE ≥ 20
- •Group C: Control subjects
- •No memory or other significant cognitive complain.
- •MMSE ≥ 24
排除标准
- •All groups :
- •Clinically significant vision abnormality(P8 without glasses)
- •Oculomotor deficit or strabismus
- •Depression (GDS) with treatment
- •Subjects unable to give their informed consent
- •Memory or any other significant cognitive complain.
- •Abnormalities at inclusion (V0) neuropsychology testing suggestive of a cognitive deficit.
结局指标
主要结局
Saccades execution parameters
时间窗: Study visit (Up to 1 month after inclusion)
To demonstrate the alteration of saccade execution parameters (latency, velocity, precision, errors) during pro and anti-saccades, spatial decision and prediction tasks in prodromal AD compared to mild to moderate AD and aged-matched controls. Variables recorded : Saccades execution parameters : * Mean latency (msec), * Mean velocity (°/msec) and maximal velocity, * Accuracy or mean gain, * Mean percent of errors and corrected errors, * Mean percent of prediction.
次要结局
- Neuropsychology tests scores(At inclusion (Day 0))
- Number of point fixation in degraded areas and of visual attention induced cards(Study visit (Up to 1 month after inclusion))
- Pre-defined variables on visual exploration tasks (fixation number and durations, errors).(Study visit (Up to 1 month after inclusion))