Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

NCT ID: NCT01937221

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Mild Cognitive Impairment Mild to Moderate Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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mild cognitive impairment

spectral-domain optical coherence tomography (SD-OCT)

Intervention Type OTHER

Intervention same to all groups.

mild to moderate cognitive impairment

spectral-domain optical coherence tomography (SD-OCT)

Intervention Type OTHER

Intervention same to all groups.

normal or control group

spectral-domain optical coherence tomography (SD-OCT)

Intervention Type OTHER

Intervention same to all groups.

Interventions

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spectral-domain optical coherence tomography (SD-OCT)

Intervention same to all groups.

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke Institute for Brain Sciences

UNKNOWN

Sponsor Role collaborator

Alzheimer's Association

OTHER

Sponsor Role collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Whitson, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Eleonora Lad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00047227

Identifier Type: -

Identifier Source: org_study_id

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