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NCT04620902 Clinical Trial

Detection of AD Biomarkers in Tear Fluid

Cognitive Impairment Clinical Trial

— SmartTears  

Official title:
Detection of AD Biomarkers in Tear Fluid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04620902
Other study ID # 15-4-100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2020

Study information
Verified date November 2020
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Detection of AD biomarkers in tear fluid

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - . Inclusion criteria were an MMSE score = 20 and a CDR score from 0 to 1, thereby including patients across the whole clinical spectrum (i.e. from subjective cognitive disorder to (mild) dementia). Exclusion Criteria: - Exclusion criteria at baseline were neurological diseases (such as Normal Pressure Hydrocephalus, Morbus Huntington, brain tumor, epilepsy, encephalitis, recent Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA) (< 2 years), or TIA/CVA with concurrent (within three months) cognitive decline) and a history of psychiatric disorders (such as schizophrenia, bipolar disorder or psychotic problems, current major depressive disorder (within 12 months), or alcohol abuse).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tear sampling
Tear sampling using Schirmer's strips

Locations
Country Name City State
Netherlands Academic Hospital Maastricht Maastricht

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of AD biomarkers in tear fluid Baseline
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