Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-28 @ 6:04 AM
Study NCT ID:
NCT02226835
Status:
TERMINATED
Last Update Posted:
2018-09-27
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Retinal Findings in People With Signs and Symptoms of Alzheimer s Disease Enrolled in 09-M-0198
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
An Investigation of Retinal Findings in Patients With Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198
Status:
TERMINATED
Status Verified Date:
2017-01-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14-EI-0173 | None | None | View |