OCT Angiography and NRAI in Dementia

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03761381

Collaborator

(none)

Enrollment

Location

50.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia Mild Cognitive Impairment	Device: Optical Coherence Tomography Angiography (OCTA) Imaging Device: Noninvasive Retinal Amyloid Imaging (NRAI)

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 14, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Early Dementia This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in two study visits, with each visit about 10 days apart.	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 RTVue-XR device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers. Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within 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.Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within the retinal layers.
Dementia-Free Controls This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in two study visits, with each visit about 10 days apart.	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 RTVue-XR device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers. Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within 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.Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within the retinal layers.

Arm

Intervention/Treatment

Early Dementia

This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in two study visits, with each visit about 10 days apart.

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 RTVue-XR device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers. Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within 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.Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within the retinal layers.

Dementia-Free Controls

This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in two study visits, with each visit about 10 days apart.

Device: Optical Coherence Tomography Angiography (OCTA) Imaging

Device: Noninvasive Retinal Amyloid Imaging (NRAI)

Outcome Measures

Primary Outcome Measures

Retinal amyloid protein detection [10 days]
OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers before and after a regimen of curcumin supplement consumption. The curcumin will serve to enhance protein detection during imaging, with OCT and OCTA imaging taken on two occasions about 10 days apart. An increase in retinal amyloid protein detection is expected in the dementia group.

Secondary Outcome Measures

Decreased blood flow [10 days]
OCT and OCT angiography will be used to detect blood flow in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on two occasions about 10 days apart. Decreased blood flow is expected in the dementia group.
Decreased retinal perfusion [10 days]
OCT and OCT angiography will be used to detect retinal perfusion deficits in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on two occasions about 10 days apart. Decreased retinal perfusion is expected in the dementia group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Huang, David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT03761381

Other Study ID Numbers:

IRB#00017045

First Posted:

Dec 3, 2018

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by David Huang, David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering, Oregon Health and Science University

Additional relevant MeSH terms:

Alzheimer Disease

Dementia

Cognitive Dysfunction

Study Results

No Results Posted as of Mar 26, 2021