Study of Retinal Findings in People With Signs and Symptoms of Alzheimer s Disease Enrolled in 09-M-0198

September 26, 2018 updated by: National Eye Institute (NEI)

An Investigation of Retinal Findings in Patients With Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198

Background:

- Alzheimer s disease affects the brain and causes memory and thinking problems in older people. Macular degeneration (MD) is an eye condition. It is the leading reason that people over age 55 in the United States lose their central vision. Central vision is important for seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye. Researchers want to learn more about these diseases and find out if they are related.

Objective:

- To see whether there is a relationship between Alzheimer s disease and age-related macular degeneration.

Eligibility:

- People with or without Alzheimer s disease enrolled in another study. Participants must have someone to help them take part in this study.

Design:

  • Participants will be screened through the other study. They will have 1 visit. The tests will take about 3 hours.
  • Participants will answer questions about their medical and eye history.
  • Participants will have an eye exam to test how well they see. Their eye pressure will be measured and their eye movements will be checked.
  • Participants will get eye drops to dilate their pupils. Researchers will take pictures of the retina and the inside of the eye. Researchers may measure the thickness of the retina.
  • Participants will continue to receive care from their regular eye doctor during and after the study.

Study Overview

Status

Terminated

Conditions

Detailed Description

Objective:

Age-related macular degeneration (AMD) and Alzheimer s disease (AD) are both neurodegenerative diseases which affect a similar demographic of patients. Beyond age being a common risk factor for both diseases, an important common characteristic is a similarity in pathology findings, specifically, the presence of amyloid (beta) (A(beta)) in the senile plaques of the AD brain and in the drusen of AMD patients. As both of these diseases are the cause of significant morbidity of the quickly growing aging population, understanding the pathogenesis of both and identification of any overlapping pathophysiology will lead to a better understanding of each disease. The objective of this study is to investigate the presence of AMD and other neurodegenerative lesions and characterize retinal findings in a group of participants with well-phenotyped AD.

Study Population:

Up to 150 participants (100 symptomatic, 50 controls) will be recruited from patients already enrolled and participating in the National Institute of Mental Health (NIMH) study, 09-M-0198, Screening and Evaluation of Patients with Signs and Symptoms of Alzheimer s Disease.

Design:

This is a single center, cross-sectional, observational study that will include a single eye clinic visit with eye exam, visual acuity, photography and optical coherence tomography (OCT) testing.

Outcome Measures:

The primary outcome is the presence of AMD or other retinal findings in patients diagnosed with AD. Secondary outcomes will include autofluorescence imaging, spectral domain OCT and visual acuity.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Patient must be enrolled in the 09-M-0198 protocol.
  • In those participants that require special assistance, we will request that they be accompanied by a care taker to provide proper care and monitoring.

EXCLUSION CRITERIA:

Patients:

  • The diagnosis of a different type of dementia, including frontotemporal dementia, normal pressure hydrocephalus, Lewy body dementia, Parkinson s disease dementia, Huntington s disease, or vascular dementia.
  • Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness other than Alzheimer s disease.
  • Behavioral symptoms that would preclude the gathering of data for the study, or advanced disease such that participants cannot provide assent.

Controls:

  • The diagnosis of a brain disorder.
  • Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Photographs and images of subjects' eyes
Time Frame: Study completion
Study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
OCT measurement
Time Frame: Study completion
Study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 13, 2014

Primary Completion (Actual)

January 24, 2017

Study Completion (Actual)

January 24, 2017

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

January 24, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140173
  • 14-EI-0173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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