Blood And Tears in Alzheimer's Disease

NCT ID: NCT06567431

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-18

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Neurodegenerative Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alzheimer's disease

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

No interventions assigned to this group

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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* No lumbar puncture
* Clinically assessed as unfit to participate in the project.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Dementia Research Centre

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish Dementia Research Centre

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Steen G Hasselbalch, DMSc

Role: CONTACT

+4535456922

Facility Contacts

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Steen Gregers Hasselbalch, DMSc

Role: primary

+45 35 45 69 22

Other Identifiers

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H-23078392

Identifier Type: -

Identifier Source: org_study_id

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