Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Study Overview
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Brief Summary
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The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).

Official Title
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Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Conditions
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Mild Cognitive Impairment, Mild to Moderate Cognitive Impairment

Intervention / Treatment
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* Other: spectral-domain optical coherence tomography (SD-OCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Result of the standard neuropsychological assessment Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years; Fluency in English Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance. Exclusion Criteria: Known or suspected diagnosis of non-AD, associated dementia; Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mild cognitive impairment<br> | Other: spectral-domain optical coherence tomography (SD-OCT)<br>* Intervention same to all groups.<br>|
| mild to moderate cognitive impairment<br> | Other: spectral-domain optical coherence tomography (SD-OCT)<br>* Intervention same to all groups.<br>|
| normal or control group<br> | Other: spectral-domain optical coherence tomography (SD-OCT)<br>* Intervention same to all groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score | The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline. | Baseline | 
| NFL/GCL abnormality score | The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have another measurement taken at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drusen/plaque score | The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subject groups at baseline. | Baseline | 
| Drusen/plaque score | The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subjects groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement at 12 months. | 12 months | 
| Total drusen area | The study will determine the significance of difference in total drusen area between the AD subject groups at baseline. | Baseline | 
| Total drusen area | The study will determine the significance of difference in total drusen area between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement taken at 12 months. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, mild to moderate cognitive impairment