Blood And Tears in Alzheimer's Disease (BAT-AD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodegenerative Diseases

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Steen G Hasselbalch, DMSc; Phone Number: +4535456922; Email: steen.gregers.hasselbalch@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Danish Dementia Research Centre
    • Contact: Steen Gregers Hasselbalch, DMSc; Phone Number: +45 35 45 69 22; Email: steen.gregers.hasselbalch@regionh.dk
    • Principal Investigator: Frederikke Kragh Clemmensen, MD
    • Principal Investigator: Anja Hviid Simonsen, MSc Pharm PhD
    • Sub-Investigator: Hannah Dabelsteen Wandall, Medical student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing dry blod spots at home	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.	Two years

Collaborators and Investigators

• Sponsor: Danish Dementia Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Alzheimer Disease; Neurodegenerative Diseases
• Other Study ID Numbers: H-23078392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No