Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Duke University

Status

Completed

Conditions

Mild Cognitive Impairment

Mild to Moderate Cognitive Impairment

Treatments

Other: spectral-domain optical coherence tomography (SD-OCT)

Study type

Observational

Funder types

Other

Identifiers

NCT01937221

Pro00047227

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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;
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

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.