RecruitingAccepts healthy volunteers

OCT Angiography and NRAI in Dementia

Oregon Health and Science University · NCT03761381

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Status re-checked against ClinicalTrials.gov within the last 12 hours.

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

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

Being studied: Optical Coherence Tomography Angiography (OCTA) Imaging; Noninvasive Retinal Amyloid Imaging (NRAI)

Conditions: Alzheimer Disease; Dementia; Mild Cognitive Impairment

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Oregon Health & Science University
Portland, OR 97239
Site contact: Denzil Romfh, OD · 503-494-4351 · romfhd@ohsu.edu