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临床试验/NCT06567431
NCT06567431招募中不适用

Examination of Alzheimer's Disease Biomarkers in Tears and Dry Blood Spots

Danish Dementia Research Centre1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
AD related biomarkers in tear fluid

研究概览

简要总结

This study aims to investigate whether biomarkers of Alzheimer's disease can be found in tearfluid, as well as dried bloodspots in patients with Alzheimer's disease, other dementia diagnoses compared to controls.

详细描述

Participants under investigation of a neurodegenerative disease who have a planned lumbar puncture in the Memory clinic will be invited to this study. On the same day of the lumbar puncture, tear fluid and dry blod spots will be collected.

Tear fluid is collected using Shirmer's test. Dried blood spots are obtained by a small prick in the finger with a lancet. The blood droplet is transferred onto a special piece of filter paper, where it dries.

As a sub-study, participants who have provided written consent specifically for this purpose will repeat the test with dried blood spots at home one week after participating in the study. The samples are submitted to the Memory Clinic at the participant's next scheduled appointment.

Tear fluid, dried blood spots, as well as blood and cerebrospinal fluid will be examined for AD-related pathology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for patients:
  • Lumbar puncture with CSF avaiable for analysis
  • Diagnosis of Alzheimer's disease, Dementia with Lewy Bodies (DLB), Frontotemporal dementia (FTD), vascular dementia (VaD) or Normal pressure hydrocephalus (NPH)
  • Of legal age.
  • Inclusion criteria for controls:
  • Lumbar puncture with CSF avaiable for analysis
  • No neurological disease.
  • Of legal age.

排除标准

  • No lumbar puncture
  • Clinically assessed as unfit to participate in the project.

结局指标

主要结局

AD related biomarkers in tear fluid

时间窗: Two years

Concentrations of AD biomarkers (AB42, AB40, Ptau217, NfL, GFAP) in tear fluid in the AD-group compared to non-AD and controls.

AD related biomarkers in dry blod spots

时间窗: Two years

Concentrations of AD biomarkers (AB42, AB40, Ptau217, NfL, GFAP) in dry blot spots in the AD-group compared to non-AD and controls.

次要结局

  • Testing dry blod spots at home(Two years)

研究者

发起方
Danish Dementia Research Centre
申办方类型
Network
责任方
Sponsor

研究点 (1)

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