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NCT Number: NCT06567431

Blood And Tears in Alzheimer's Disease

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Dementia Research Centre

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Anja Hviid Simonsen, MSc Pharm PhD

PRINCIPAL_INVESTIGATOR

Frederikke Kragh Clemmensen, MD

PRINCIPAL_INVESTIGATOR

Hannah Dabelsteen Wandall, Medical student

SUB_INVESTIGATOR

Steen Gregers Hasselbalch, DMSc

CONTACT

[email protected]

+45 35 45 69 22

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. AD related biomarkers in tear fluid

    Time frame: Two years

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

  2. AD related biomarkers in dry blod spots

    Time frame: 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 outcomes

  1. Testing dry blod spots at home

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Steen G Hasselbalch, DMSc

CONTACT

[email protected]

+4535456922

Sponsors and collaborators

Lead sponsor

Danish Dementia Research Centre

Network

Registry information

Official study title

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

Acronym: BAT-AD

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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