Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01937221

Enrollment

Registered

2013-09-09

Start date

2013-09-30

Completion date

2017-07-31

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Mild to Moderate Cognitive Impairment

Keywords

mild cognitive impairment, mild to moderate cognitive impairment

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).

Interventions

OTHERspectral-domain optical coherence tomography (SD-OCT)

Intervention same to all groups.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Result of the standard neuropsychological assessment 2. 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; 3. Fluency in English 4. 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

1. Known or suspected diagnosis of non-AD, associated dementia; 2. 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Total drusen area	Baseline	The study will determine the significance of difference in total drusen area between the AD subject groups at baseline.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026