Atlas of Retinal Imaging in Alzheimer's Study

NCT03862222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2025-06-05

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862222 on ClinicalTrials.gov