Age-Related Macular DegenerationNCT02226835
Study of Retinal Findings in People With Signs and Symptoms of Alzheimer s Disease Enrolled in 09-M-0198
An observational study of Age-Related Macular Degeneration and Alzheiner's Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration, Alzheiner's Disease, AMD
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2014to 24 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Age-Related Macular Degeneration, Alzheiner's Disease, AMD
- Keywords
- OCT, Alzheimer's Disease, Age-Related Macular Degeneration (AMD)
- Medical subject headings
- Macular Degeneration, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographs and images of subjects' eyes
Measured: Study completion
Secondary outcomes (1)
OCT measurement
Measured: Study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study start13 Aug 2014
- Primary completion24 Jan 2017
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Catherine A Cukras, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226835
- Sponsor's protocol ID
- 140173
- Other IDs
- 14-EI-0173
- Status last verified
- 24 Jan 2017
- First submitted
- 26 Aug 2014
- Last updated
- 27 Sep 2018
- Results posted
- No
Publications
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.
PubMed 15078675Ferris 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.
PubMed 6208888Hebert 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.
PubMed 12925369
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Retinal Findings in Patients With Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198
- ClinicalTrials.gov ID
- NCT02226835
- Acronym / sponsor ID
- 140173
- Conditions
- Age-Related Macular Degeneration, Alzheiner's Disease, AMD
- Keywords
- OCT, Alzheimer's Disease, Age-Related Macular Degeneration (AMD)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 13 Aug 2014
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- The diagnosis of a brain disorder.
- Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Photographs and images of subjects' eyes
Time frame: Study completion
1 secondary outcome
OCT measurement
Time frame: Study completion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Background: PubMed 15078675Friedman 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.
- Background: PubMed 6208888Ferris 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.
- Background: PubMed 12925369Hebert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A Cukras, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration and Alzheiner's Disease, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographs and images of subjects' eyes (time frame: Study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226835, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.