Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

NCT01937221 | Completed

• 1 other identifier: Pro00047227
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment; Mild to Moderate Cognitive Impairment

Keywords

mild cognitive impairment; mild to moderate cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Drusen/plaque score

  Baseline

• Drusen/plaque score

  12 months

• Total drusen area

  Baseline

• Total drusen area

  12 months

Study Arms (3)

mild cognitive impairment

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

mild to moderate cognitive impairment

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

normal or control group

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

Interventions

spectral-domain optical coherence tomography (SD-OCT) OTHER

Intervention same to all groups.

mild cognitive impairment; mild to moderate cognitive impairment; normal or control group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Known or suspected diagnosis of non-AD, associated dementia;

Sponsors & Collaborators

• Duke University: lead
• Duke Institute for Brain Sciences: collaborator
• Alzheimer's Association: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Heather Whitson, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

• Eleonora Lad, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 31, 2019

Record last verified: 2017-12

Locations

US (1)