Overview

This trial is active, not recruiting.

Conditions mild cognitive impairment, mild to moderate cognitive impairment
Treatment spectral-domain optical coherence tomography (sd-oct)
Sponsor Duke University
Collaborator Duke Institute for Brain Sciences
Start date September 2013
End date September 2017
Trial size 60 participants
Trial identifier NCT01937221, Pro00047227

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
spectral-domain optical coherence tomography (sd-oct)
Intervention same to all groups.
spectral-domain optical coherence tomography (sd-oct)
Intervention same to all groups.
spectral-domain optical coherence tomography (sd-oct)
Intervention same to all groups.

Primary Outcomes

Measure
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
time frame: Baseline
NFL/GCL abnormality score
time frame: 12 months

Secondary Outcomes

Measure
Drusen/plaque score
time frame: Baseline
Drusen/plaque score
time frame: 12 months
Total drusen area
time frame: Baseline
Total drusen area
time frame: 12 months

Eligibility Criteria

Male or female participants at least 55 years old.

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.

Additional Information

Official title Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
Principal investigator Heather Whitson, MD, MHS
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Duke University.