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

NCT02226835 | Terminated

• 2 other identifiers: 14017314-EI-0173
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration; Alzheiner's Disease; AMD

Keywords

OCT; Alzheimer's Disease; Age-Related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

• Photographs and images of subjects' eyes

  Study completion

Secondary Outcomes (1)

• OCT measurement

  Study completion

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.

  PMID: 15078675 BACKGROUND

• Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.

  PMID: 6208888 BACKGROUND

• Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA. Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol. 2003 Aug;60(8):1119-22. doi: 10.1001/archneur.60.8.1119.

  PMID: 12925369 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Alzheimer Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Catherine A Cukras, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: August 13, 2014
• Primary Completion: January 24, 2017
• Study Completion: January 24, 2017
• Last Updated: September 27, 2018

Record last verified: 2017-01-24

Locations

US (1)