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OCT Angiography and NRAI in Dementia

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ClinicalTrials.gov Identifier: NCT03761381
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

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.

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

Study Type : Observational
Estimated 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 : September 14, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort 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.




Primary Outcome Measures :
  1. Retinal amyloid protein detection [ Time Frame: 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 :
  1. Decreased blood flow [ Time Frame: 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.

  2. Decreased retinal perfusion [ Time Frame: 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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761381


Contacts
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu
Contact: Humberto Martinez, COT 503-494-7712 martinhu@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Denzil Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Contact: Humberto Martinez, COT    503-494-7712    martinhu@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: David Huang, MD, PhD Oregon Health and Science University

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     History of Changes
Other Study ID Numbers: IRB#00017045
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Huang, Oregon Health and Science University:
MCI
OCT
Angiography
Alzheimer's
Dementia

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders