Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Mild to Moderate Cognitive Impairment
• Intervention / Treatment: Other: spectral-domain optical coherence tomography (SD-OCT)

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal controls and patients with mild, mild to moderate cognitive impairment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild cognitive impairment	Other: spectral-domain optical coherence tomography (SD-OCT); Intervention same to all groups.
mild to moderate cognitive impairment	Other: spectral-domain optical coherence tomography (SD-OCT); Intervention same to all groups.
normal or control group	Other: spectral-domain optical coherence tomography (SD-OCT); Intervention same to all groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score	The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.	Baseline
NFL/GCL abnormality score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drusen/plaque score	The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subject groups at baseline.	Baseline
Drusen/plaque score	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.	12 months
Total drusen area	The study will determine the significance of difference in total drusen area between the AD subject groups at baseline.	Baseline
Total drusen area	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.	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Alzheimer's Association; Duke-NUS Graduate Medical School; Duke Institute for Brain Sciences
• Investigators: Principal Investigator: Heather Whitson, MD, MHS, Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: mild cognitive impairment; mild to moderate cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: Pro00047227