Blood And Tears in Alzheimer's Disease

NCT06567431 | Recruiting

• 1 other identifier: H-23078392
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (2)

• AD related biomarkers in tear fluid

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

  Two years

• AD related biomarkers in dry blod spots

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

  Two years

Secondary Outcomes (1)

• Testing dry blod spots at home

  Two years

Study Arms (3)

Alzheimer's disease

Patients diagnosed with Alzheimer's disease (AD), either MCI, mild or moderate dementia.

Cognitive impairment due to non-Alzheimer's disease

Patients diagnosed with one of the following dementia disorders: Dementia with Lewy Bodies (DLB), Frontotemporal dementia (FTD), vascular dementia (VaD) and Normal pressure hydrocephalus (NPH).

Controls

Patients who have undergone a diagnostic work-up in a memory clinic, but no neurodegenerative or other neurological disease was found, serve as control group.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include 177 participants in each group. The diagnoses are based on internationally recognised diagnostic criteria for the individual diseases, and the diagnosis is made at a consensus conference by experienced specialists in the field of dementia.

You may qualify if:

• 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.
• Lumbar puncture with CSF avaiable for analysis
• No neurological disease.
• Of legal age.

You may not qualify if:

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

Sponsors & Collaborators

• Danish Dementia Research Centre: lead

Study Sites (1)

Danish Dementia Research Centre

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears and dry blood spots from fingerprick

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Steen G Hasselbalch, DMSc

CONTACT

+4535456922; steen.gregers.hasselbalch@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: August 22, 2024
• Study Start: March 18, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)