Atlas of Retinal Imaging in Alzheimer's Study
NCT03862222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 165
Last updated 2025-06-05
Summary
The Atlas of Retinal Imaging in Alzheimer's (ARIAS) study is a 5-year study examining the natural history of retinal imaging biomarkers associated with disease risk, disease burden, and disease progression in Alzheimer's disease (AD). The objective of this project is to create a 'gold standard' reference database of structural anatomic and functional imaging of the retina, in order to enable the identification and development of both sensitive and reliable markers of AD risk and/or progression. Our ultimate goal is to develop a new screening protocol that identifies changes related to AD 10-20 years before AD is clinically visible.
Conditions
- Alzheimer Disease
- Mild Cognitive Impairment
- Mild Dementia
- Aging
- Cognitive Change
Interventions
- OTHER
-
Retinal Imaging
Retinal imaging will be conducted on the Heidelberg SPECTRALIS (FDA 510k cleared) device, routinely used in clinical care in ophthalmology. Optical Coherence Tomography (OCT) and Angiography (OCT-A) sequences will be conducted, as well as a sequence examining macular pigment (MPOD).
- OTHER
-
Pupillometry
Participants will complete a task studying pupillary response to light
- OTHER
-
Contrast Sensitivity
Participants will complete a task evaluating contrast sensitivity
- DIAGNOSTIC_TEST
-
Neuropsychological Evaluation
Neuropsychological evaluation will be completed, including testing in domains of memory, executive function, visuospatial ability, language, processing speed. Results will be used for research purposes only.
- GENETIC
-
APOE genotyping
APOE genotyping will be completed during screening to assign participants to the correct group. Results will not be shared with participants as part of the study.
- OTHER
-
blood draw
Blood will be drawn and banked for proteomic, biomarker, and GWAS analysis
- OTHER
-
Gait Assessment
Gait assessment will be conducted by trained researcher
- OTHER
-
Actigraphy
Actigraphy monitors will be worn by all participants for 2 weeks after each visit to examine physical activity, movement, and sleep patterns.
Sponsors & Collaborators
-
BayCare Health System
collaborator OTHER -
University of Rhode Island
lead OTHER
Principal Investigators
-
Stuart Sinoff, MD · BayCare Health System
-
Peter J Snyder, PhD · University of Rhode Island
Eligibility
- Min Age
- 55 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-12-16
- Primary Completion
- 2022-12-31
- Completion
- 2025-05-31
Countries
- United States
Study Locations
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