Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20 participants
OBSERVATIONAL
2018-09-14
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optical Coherence Tomography in Cerebral Amyloidosis
NCT03472482
Comparison of OCTA Factors in Patients With or Without Amyloid Pathology: A Prospective Study
NCT05475158
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
NCT04389437
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
NCT04794634
Detecting Dementia in the Retina Using Optical Coherence Tomography
NCT03631069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early Dementia
This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
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.
Dementia-Free Controls
This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
* 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.
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Huang
David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Huang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health & Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB#00017045
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.