| NCT ID | NCT03761381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2018-09-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2018-09-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
David Huang, MD, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT03761381 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03761381 currently recruiting?
Yes, NCT03761381 is actively recruiting participants. Contact the research team at romfhd@ohsu.edu for enrollment information.
Where is the NCT03761381 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03761381 clinical trial?
NCT03761381 is sponsored by Oregon Health and Science University. The principal investigator is David Huang, MD, PhD at Oregon Health and Science University. The trial plans to enroll 20 participants.
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