Study of Retinal Findings in People With Signs and Symptoms of Alzheimer s Disease Enrolled in 09-M-0198
| Status: | Terminated |
|---|---|
| Conditions: | Alzheimer Disease, Ocular |
| Therapuetic Areas: | Neurology, Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 9/29/2018 |
| Start Date: | August 13, 2014 |
| End Date: | January 24, 2017 |
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.
- 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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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