This study aims to investigate the retina, macula and optic nerve head with Optical Coherence Tomography (OCT) in a cohort of AD patients in order to identify a neurodegenerative signature of AD consisting of neuroretinal degeneration, vascular…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- OCT: thickness of the individual retinal layers, including the choroid, at
the macular region and optic disc
- PS-OCT: presence (and number) of amyloid plaques, thickness and change in
birefringence of RNFL
- Angio-OCT: changes in vessel density around the optic nerve head
Secondary outcome
- Relate the amount of visualized A*-plaques in the retina of AD patients to
other available AD biomarkers (i.e. hippocampal atrophy, CSF biomarkers and
amyloid PET scan).
- Compare findings of standard OCT with available biomarkers (i.e. hippocampal
atrophy, CSF biomarkers and amyloid PET scan)
- Compare findings in vessel density around the optic nerve head to
existing vascular markers (scores on MRI)
Background summary
The diagnosis of Alzheimer*s disease is based on clinical criteria supported
by either MRI or PET scan or CSF analysis. These investigations are expensive
and/or invasive. The retina is embryologically derived from the brain and
shares many tissue similarities with the cerebral cortex. With ophthalmological
examination, the retina is easily accessible for investigation. Thus, the
retina may be of interest as a *window to the brain* and a potential new
diagnostic goal for early diagnosis of AD and/or follow-up of possibly
therapeutic agents.
Study objective
This study aims to investigate the retina, macula and optic nerve head with
Optical Coherence Tomography (OCT) in a cohort of AD patients in order to
identify a neurodegenerative signature of AD consisting of neuroretinal
degeneration, vascular changes and visualization amyloid-beta (A*) on the
other. In addition to a previous pilot we intend to include a larger cohort of
both early onset (EOAD) and late onset AD patients (LOAD), aim to visualize A*
with the help of polarization sensitive OCT (PS-OCT) and see if there are
vascular changes around the optic nerve head using an angio-OCT. With the use
of intra-ocular pressure, a HRT (Heidelberg Retina Tomograph)-scan and FDT
(Frequency Doubling Technology), we aim to exclude glaucoma; an important
confounder in the relation between neurodegenerative disease and retinal
neurodegeneration.
Study design
This is an observational cohort study as an extension of the pilot *The retina
as a potential window to visualize neuropathology in Alzheimer's disease*.
Study burden and risks
Patients will have one extra site visit, next tot the regular visits for
patient care in the VUmc Alzheimer Center. During this visit, their pupils will
be dilated using tropicamide 0.5%, possibly causing temporary blurry vision and
mild transient photophobia (lasting several hours). This may interfere with car
driving, so patients are advised not to drive themselves. Adverse coular or
systemic side effect are very rare. Baseline ophthalmological investigations
include OCT, angio-OCT, FDT and HRT. Both these and the newly developed PS-OCT
are non-invasive optical eye examinations in which light is used to examine the
posterior part of the eye. The used wavelenght and the overall energy level of
the light is well below the safety margins and is harmless and without risks.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- Study cases: patients with AD fulfilling the clinical criteria, a MMSE-score of at least 17/30 and proven to be amyloid positive by either decreased CSF A* or a positive amyloid PET scan.
- Controls: patients with subjective memory complaints visiting the Alzheimer center, without diagnosis of AD or other neurodegenerative disease, proven to be amyloid negative by either normal CSF A* or negative amyloid PET scan.
Exclusion criteria
- Subjects with neuro-opthalmological conditions which may interfere with the OCT data
- Subjects with progressive dementia, with an MMSE below 17/30 and/or incapacitated and not capable to give informed consent.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL57669.029.16 |