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临床试验/NCT04389437
NCT04389437招募中不适用

OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
450
试验地点
2
主要终点
Wall to lumen ratio (WLR)

研究概览

简要总结

Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases.

These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD.

No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint

排除标准

  • pregnant or lactating women
  • history of known non-degenerative neurological pathology (tumor, stroke territorial, in particular multiple sclerosis)
  • history of retinal pathology
  • ametropia greater in absolute value than 3 diopters on the sphere, or/and 1.5 diopters on the cylinder.
  • history of taking ethambutol for more than 2 months
  • history of takingsynthetic antimalarial for more than 2 years
  • Mini Mental State Score (MMS) and / or Montreal Cognitive Assessment (MoCA) <10 for patients and 26 for accompanying persons
  • MRI contraindication (for patients only)

结局指标

主要结局

Wall to lumen ratio (WLR)

时间窗: Baseline (Inclusion)

Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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