Retinal Imaging in Neurodegenerative Disease

NCT ID: NCT03233646

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.

The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.

This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.

The protocol for this study was amended and the record was updated accordingly.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Mild Cognitive Impairment Parkinson's Disease Multiple Sclerosis Huntington Disease Lewy Body Dementia Frontotemporal Dementia Amyotrophic Lateral Sclerosis (ALS) APOE-4 Positive Traumatic Brain Injury Concussion Post-Traumatic Stress Disorder Down Syndrome Neuro-Degenerative Disease Normal Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case

Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

Retinal and Choroidal Imaging

Intervention Type DEVICE

Non-invasive OCT, OCTA, and UWF fundus photography of retina

Controls

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Retinal and Choroidal Imaging

Intervention Type DEVICE

Non-invasive OCT, OCTA, and UWF fundus photography of retina

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Retinal and Choroidal Imaging

Non-invasive OCT, OCTA, and UWF fundus photography of retina

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
* Adults without neurodegenerative disease

Exclusion Criteria

* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
* Eyes that have had intraocular surgery, other than cataract surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Edinburgh in Scotland

UNKNOWN

Sponsor Role collaborator

Tan Tock Seng Hospital in Singapore

UNKNOWN

Sponsor Role collaborator

Queens University of Belfast United Kingdom

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharon Fekrat, MD FACS FASRS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Dilraj Grewal, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sharon Fekrat, MD FACS FASRS

Role: CONTACT

919-681-3937

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sharon Fekrat, MD FACS FASRS

Role: primary

919-681-3937

References

Explore related publications, articles, or registry entries linked to this study.

Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186/s12886-025-04157-x.

Reference Type DERIVED
PMID: 40598011 (View on PubMed)

Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097/IAE.0000000000003458.

Reference Type DERIVED
PMID: 35723922 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00111831

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eye Scanning for Safety Driving
NCT06396273 ACTIVE_NOT_RECRUITING