To investigate whether tear biomarkers can differentiate between patients and controls, and between patient groups.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
- No intervention
N.a.
Outcome measures
Primary outcome
<p>The main study parameter is the difference in level of tear biomarkers (such as<br />
amyloid-beta and tau) between patients and controls, and between patient<br />
groups. </p>
Secondary outcome
<p>The correlation between tear biomarkers with CSF and blood biomarkers.<br />
The correlation between tear biomarkers and other ocular imaging biomarkers</p>
Background summary
The eyes and the brain are closely connected through the optic nerve (Fig.1A)
and both the retina and the central nervous system share a common origin from
the developing neural tube. Given this relation, eye problems often reflect
brain problems. For example, AD patients suffer from several visual problems
including loss of visual acuity, color vision and visual fields and changes in
pupillary response, fixation and contrast sensitivity. We hypothesize that tear
fluid is a non-invasive source of biomarkers for Alzheimer*s disease (AD).
Study objective
To investigate whether tear biomarkers can differentiate between patients and
controls, and between patient groups.
Study design
Case-control observational single-center study
Intervention
Not applicable
Study burden and risks
The expected risks are low because of the non-invasive nature of the study. The
study includes one visit of 120 min at which ophthalmic measurements are
performed. There are no direct benefits for subjects participating in this
study
M Gijs
P. Debyelaan 25
Maastricht 6229 HX
Netherlands
0618064496
marlies.gijs@mumc.nl
M Gijs
P. Debyelaan 25
Maastricht 6229 HX
Netherlands
0618064496
marlies.gijs@mumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Written informed consent obtained and documented
Capable of giving informed consent themselves (MMSE score > 17/30)*
Exclusion criteria
Ocular conditions that could influence tear biochemical parameters (including
eye infection, eye inflammation, eye surgery within the last 28 days or other
acute eye conditions)
Neurological or systemic chronic conditions known to interfere with retinal
thickness (e.g., glaucoma, diabetes mellitus)
Ocular conditions interfering with OCT quality/retinal thickness: e.g. severe
cataract, age-related macular degeneration, and glaucoma
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05655793 |
| CCMO | NL73600.068.20 |
| Research portal | NL-008239 |