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Recruiting NCT06567431

Blood And Tears in Alzheimer's Disease

Observational Neurodegenerative Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neurodegenerative Diseases. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • AD related biomarkers in tear fluid [Time frame: Two years]
  • AD related biomarkers in dry blod spots [Time frame: Two years]
Secondary outcome measures (1)
  • Testing dry blod spots at home [Time frame: Two years]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Danish Dementia Research Centre — Copenhagen

Identifiers

NCT: NCT06567431 · H-23078392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗