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Blood And Tears in Alzheimer's Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06567431
Acronym
BAT-AD
Enrollment
600
Registered
2024-08-22
Start date
2024-03-18
Completion date
2028-12-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Diseases

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.

Interventions

None listed

Sponsors

Danish Dementia Research Centre
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AD related biomarkers in tear fluidTwo yearsConcentrations 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 spotsTwo yearsConcentrations of AD biomarkers (AB42, AB40, Ptau217, NfL, GFAP) in dry blot spots in the AD-group compared to non-AD and controls.

Secondary

MeasureTime frameDescription
Testing dry blod spots at homeTwo yearsTo 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.

Countries

Denmark

Contacts

Primary ContactSteen G Hasselbalch, DMSc
steen.gregers.hasselbalch@regionh.dk+4535456922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026