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Trial record 2 of 2 for:    eleonora lad

Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01937221
First Posted: September 9, 2013
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke Institute for Brain Sciences
Alzheimer's Association
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Duke University
  Purpose
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).

Condition Intervention
Mild Cognitive Impairment Mild to Moderate Cognitive Impairment Other: spectral-domain optical coherence tomography (SD-OCT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal controls and patients with mild, mild to moderate cognitive impairment
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937221


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Duke Institute for Brain Sciences
Alzheimer's Association
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Heather Whitson, MD, MHS Duke University
Principal Investigator: Eleonora Lad, MD, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01937221     History of Changes
Other Study ID Numbers: Pro00047227
First Submitted: September 4, 2013
First Posted: September 9, 2013
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Duke University:
mild cognitive impairment
mild to moderate cognitive impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders