Blood And Tears in Alzheimer's Disease

Recruiting

• Conditions: Neurodegenerative Diseases

• Registration Number: NCT06567431
• Lead Sponsor: Danish Dementia Research Centre

Brief Summary

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.

Study Timeline

• Study Start: 2024-03-18
• Study First Submitted: 2024-03-18
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-01-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AD related biomarkers in tear fluid	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	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.

Secondary Outcome Measures

Name	Time	Method
Testing dry blod spots at home	Two years	To test the feasability of dry blod spots card in a home setting - measuring concentrations of AD biomarkers in the blod cards performed at home compared to the card performed in the clinic.

Trial Locations

Locations (1)

Danish Dementia Research Centre; 🇩🇰 Copenhagen, Denmark