Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| mild cognitive impairment
|
Other: spectral-domain optical coherence tomography (SD-OCT)
Intervention same to all groups.
|
| mild to moderate cognitive impairment
|
Other: spectral-domain optical coherence tomography (SD-OCT)
Intervention same to all groups.
|
| normal or control group
|
Other: spectral-domain optical coherence tomography (SD-OCT)
Intervention same to all groups.
|
Outcome Measures
Primary Outcome Measures
- Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score [Baseline]
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.
- NFL/GCL abnormality score [12 months]
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.
Secondary Outcome Measures
- Drusen/plaque score [Baseline]
The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subject groups at baseline.
- Drusen/plaque score [12 months]
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.
- Total drusen area [Baseline]
The study will determine the significance of difference in total drusen area between the AD subject groups at baseline.
- Total drusen area [12 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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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:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- Duke Institute for Brain Sciences
- Alzheimer's Association
- Duke-NUS Graduate Medical School
Investigators
- Principal Investigator: Heather Whitson, MD, MHS, Duke University
- Principal Investigator: Eleonora Lad, MD, PhD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00047227