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Detection of AD Biomarkers in Tear Fluid (SmartTears)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04620902
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:
Detection of AD biomarkers in tear fluid

Condition or disease Intervention/treatment
Cognitive Impairment Other: Tear sampling

Study Design
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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of AD Biomarkers in Tear Fluid
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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Group/Cohort Intervention/treatment
Dementia
Dementia
 Other: Tear sampling
Tear sampling using Schirmer's strips
MCI
Mild cognitive impairment
 Other: Tear sampling
Tear sampling using Schirmer's strips
SCD
Subjective cognitive decline
 Other: Tear sampling
Tear sampling using Schirmer's strips
HC
Cognitively healthy control
 Other: Tear sampling
Tear sampling using Schirmer's strips


Outcome Measures
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Primary Outcome Measures :
  1. Level of AD biomarkers in tear fluid [ Time Frame: Baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A total of 60 patients and nine cognitively healthy age-matched controls (HC) were enrolled in this study.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620902


Locations
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Netherlands
Academic Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04620902    
Other Study ID Numbers: 15-4-100
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders