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Completed

NCT Number: NCT01937221

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).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Mild to Moderate Cognitive Impairment Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

spectral-domain optical coherence tomography (SD-OCT)

Other

Intervention same to all groups.

Primary outcomes

  1. Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score

    Time frame: Baseline

    The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.

  2. NFL/GCL abnormality score

    Time frame: 12 months

    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.

Secondary outcomes

  1. Drusen/plaque score

    Time frame: Baseline

    The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subject groups at baseline.

  2. Drusen/plaque score

    Time frame: 12 months

    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.

  3. Total drusen area

    Time frame: Baseline

    The study will determine the significance of difference in total drusen area between the AD subject groups at baseline.

  4. Total drusen area

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Alzheimer's Association
  • Duke Institute for Brain Sciences
  • Duke-NUS Graduate Medical School

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2013
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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