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Recruiting NCT03761381

OCT Angiography and NRAI in Dementia

— Observational Alzheimer Disease Dementia Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical Coherence Tomography Angiography (OCTA) Imaging, Noninvasive Retinal Amyloid Imaging (NRAI).
Who it may be relevant to
Registry conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia

Overview

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.

Interventions

  • Device Optical Coherence Tomography Angiography (OCTA) Imaging
    Optical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The Solix device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers.
  • Device Noninvasive Retinal Amyloid Imaging (NRAI)
    The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye.

Primary outcome measures

  • Retinal amyloid protein detection [Time frame: 1 day]
Secondary outcome measures (2)
  • Decreased blood flow [Time frame: 1 day]
  • Decreased retinal perfusion [Time frame: 1 day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT03761381 · IRB#00017045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗