Retinal Neurodegenerative Signs in Alzheimer's Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
研究概览
简要总结
A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.
Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.
It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for AD cases:
- •Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51
- •Light to moderate severity of the disease, defined by a MMSE score >10 (global evaluation of cognition)
- •Patient aged 50 years or more
- •Patient benefiting from social insurance
- •Inclusion criteria for controls:
- •Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as:
- •Free recall ≥17 and total recall ≥40 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE ≥ norm for age and educational level (defined by mean - 1 SD)
- •Isaac's set test ≥ norm for age and educational level (defined by mean - 1 SD)
- •Matched to age and gender of the cases
- •Patient benefiting from social insurance
排除标准
- •Exclusion criteria for all patients :
- •History of Parkinson's disease or other neurodegenerative disorder
- •History of Horton's disease
- •History of inflammatory neuropathies (in particular Devic's disease, multiple sclerosis)
- •History of vascular ischemic neuropathies and chronic intracranial hypertension
- •History of pituitary tumors
- •Presence of diseases (systemic and/or ocular diseases) or behavioural or cognitive symptoms incompatible with eye examination
- •Known diabetes
- •Person under tutorship or curatorship, person unable to express consent
- •Additional exclusion criteria for AD cases:
- •Dementia of other cause than AD
- •Severe AD, defined by MMSE score ≤ 10
- •Additional exclusion criteria for controls:
- •Presence of dementia, of whatever cause
研究组 & 干预措施
Alzheimer Disease
干预措施: Ophthalmological examination & Questionnaire (Other)
Control
干预措施: Ophthalmological examination & Questionnaire (Other)
结局指标
主要结局
RNFL thickness measured on a peri-papillary scan of SD-OCT examination.
时间窗: inclusion visit (day0)
次要结局
- Macular and peripheral abnormalities diagnosed in wide-field retinal imaging(inclusion visit (day0))
- Macular abnormalities observed on macular scans in SD-OCT (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, epiretinal membranes, other retinal diseases).(inclusion visit (day0))
- Retinal blood flow velocity (RFI)(inclusion visit (day0))
- Intraocular pressure(inclusion visit (day0))
- Glaucomatous optic nerve damage observed on colour photographs (cup/disc ratio)(inclusion visit (day0))
- Retinal microvascular abnormalities (microaneurysms, micro-hemorrhage, cotton wool spots, arteriovenous nicking), observed on retinal colour photography(inclusion visit (day0))
- axial length(inclusion visit (day 0))
- Macular abnormalities observed on retinal colour photographs (drusen, pigmentary abnormalities, neovascular AMD, atrophic AMD, other retinal diseases)(inclusion visit (day0))
- Macular abnormalities observed in autofluorescence imaging (increased autofluorescence, decreased autofluorescence, reticular drusen, atrophic AMD, other abnormalities)(inclusion visit (day0))