No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Study type
Observational
Participants needed
20 (estimated)
Sponsor
Oregon Health and Science University · Other
Who this trial is looking for
This trial is looking for people aged over 55 with mild dementia or Alzheimer's disease. Participants will have tests to check their eye health and blood flow in the retina.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with probable Alzheimer's disease.
I have mild dementia with a score of 20 or greater on the Mini-Mental State Exam.
I am older than 55 years.
I can follow the study procedures.
I can see well enough, at least 20/400 in either eye.
I have someone who can help me with consent and attend visits.
You may not be able to join if
I have another neurological disease like multiple sclerosis or Parkinson's.
I have had other eye problems that could affect the study.
I have had eye surgery other than cataract removal.
I cannot keep my eyes steady for the imaging.
I can't provide informed consent.
I have uncontrolled high blood pressure.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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…
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.
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