Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Completed

• Conditions: Mild Cognitive Impairment; Mild to Moderate Cognitive Impairment
• Interventions: Other: spectral-domain optical coherence tomography (SD-OCT)

• Registration Number: NCT01937221
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-12
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mild cognitive impairment	spectral-domain optical coherence tomography (SD-OCT)	-
normal or control group	spectral-domain optical coherence tomography (SD-OCT)	-
mild to moderate cognitive impairment	spectral-domain optical coherence tomography (SD-OCT)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Drusen/plaque score	12 months	The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subjects groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement at 12 months.
Total drusen area	12 months	The study will determine the significance of difference in total drusen area between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement taken at 12 months.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States