OCT Angiography and NRAI in Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03761381
• Other study ID #: IRB#00017045
• Status: Recruiting
• Start date: September 14, 2018
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Denzil Romfh, OD
• Phone: 503-494-4351
• Email: romfhd[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal amyloid protein detection	OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers on the single enrollment visit only. An increase in the protein detection is expected in the dementia group.	1 day
Secondary	Decreased blood flow	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 the single enrollment visit only. Decreased blood flow is expected in the dementia group.	1 day
Secondary	Decreased retinal perfusion	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 a single enrollment visit only. Decreased retinal perfusion is expected in the dementia group.	1 day