Using retinal imaging to study blood flow and amyloid deposits in dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to utilize optical coherence tomography (OCT) angiography to assess changes in retinal blood vessels and blood flow in individuals diagnosed with dementia. Additionally, it seeks to identify amyloid protein deposits in the retinas of these participants. The study will include both individuals with dementia and dementia-free controls to compare findings. Participants will undergo noninvasive retinal imaging procedures to gather data on these conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: David Huang, MD, PhD — Oregon Health and Science University
• Study coordinator: Denzil Romfh, OD
• Email: romfhd@ohsu.edu
• Phone: 503-494-4351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.