NCT04620902

Brief Summary

Detection of AD biomarkers in tear fluid

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 3, 2020

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of AD biomarkers in tear fluid

    Baseline

Study Arms (4)

Dementia

Dementia

Other: Tear sampling

MCI

Mild cognitive impairment

Other: Tear sampling

SCD

Subjective cognitive decline

Other: Tear sampling

HC

Cognitively healthy control

Other: Tear sampling

Interventions

Tear sampling using Schirmer's strips

DementiaHCMCISCD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 60 patients and nine cognitively healthy age-matched controls (HC) were enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Hospital Maastricht

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations