Clinical trial NCT03761381: OCT Angiography and NRAI in Dementia
Official title: Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Keywords: MCI
OCT
Angiography
Alzheimer's
Dementia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dementia subjects will be recruited from the Layton Aging \& Alzheimer's Disease Clinic at Oregon Health \& Science University. Dementia-free subjects will be recruited from those currently being followed in the Layton Aging \& Alzheimer's Disease Center longitudinal aging study with MRI and amyloid PET imaging.

Brief summary: The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:

1. Detect retinal blood vessel and blood flow changes in participants with dementia.
2. Detect amyloid protein deposits in the retinas of participants with dementia.


Eligibility criteria: Inclusion Criteria for dementia subjects:

* Physician-confirmed diagnosis of probable Alzheimer's disease
* Mild dementia, as defined by score of 20 or greater on the Mini-Mental State Exam, or score of 15 or greater on the Montreal Cognitive Assessment, or Clinical Dementia Rating Scale score of 1.
* Age older than 55 years.
* Able to comply with study procedures
* Corrected visual acuity at least 20/400 in either eye.
* Has a legally authorized representative who can sign study consent form and accompany the participant to the OCT study visit.

Inclusion Criteria for dementia-free controls:

* Age older than 55 years
* Able to comply with study procedures
* Able to maintain stable fixation for OCT imaging
* Corrected visual acuity of at least 20/40 in either eye
* Dementia-free, as defined by score of 24 or greater on the Mini-Mental Status Exam, or a score of 18 or greater on the Montreal Cognitive Assessment, or Clinical Dementia Rating of \<1.0.

Exclusion Criteria for both dementia and dementia-free subjects:

* Non-Alzheimer's disease related primary neurologic disease affecting the central nervous system (i.e. multiple sclerosis, Parkinson's disease)
* Evidence on ophthalmological exam within the last year of other ocular diseases or pathology that would confound the assessment of dementia (e.g. glaucoma, diabetic or hypertensive retinal disease, amblyopia, etc.)
* Media opacity such as cataract, corneal scar, or vitreous opacity that could interfere with retinal imaging.
* Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
* Inability to maintain stable fixation for OCT imaging or provide informed consent
* Spherical equivalent refractive error greater than +3 or -7 diopters, or astigmatism magnitude of greater than 2 diopters.
* Diabetes for more than 10 years or hemoglobin A1C level of \> 10 within the 180 days prior to OCT scanning.
* Uncontrolled hypertension. : SBP \> 170 or DBP \> 100
* Arrhythmia: irregular pulse, or heart rate not between 50 and 110 beats per minute
* Pregnancy or breast feeding.

Primary outcomes:
measure: Retinal amyloid protein detection
timeFrame: 1 day
Secondary outcomes:
measure: Decreased blood flow
timeFrame: 1 day
measure: Decreased retinal perfusion
timeFrame: 1 day
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: