Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Mild Cognitive Impairment Clinical Trial

Official title:

Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937221
• Other study ID #: Pro00047227
• Status: Completed
• Start date: September 2013
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild to Moderate Cognitive Impairment

Intervention

Other:
• spectral-domain optical coherence tomography (SD-OCT)
Intervention same to all groups.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Alzheimer's Association, Duke Institute for Brain Sciences, Duke-NUS Graduate Medical School

Country where clinical trial is conducted

United States, 

Outcome

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