Age-Related Macular DegenerationNCT01996215
Brain Connectivity in Age-Related Macular Degeneration
An observational study of Age-Related Macular Degeneration, run by Duke University at 1 site in United States.
Trial summary
This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2018
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include 300 participants: 150 subjects with AMD plus 150 age, gender, and education-matched adults without AMD. All participants will receive baseline and 2 year neurocognitive tests and a subset will provide structural and "resting stage"functional magnetic resonance images (MRIs) at each time point.
Who may be able to join
- AMD
- Vision loss attributable to AMD
- Controls
- Age match (± 5 yrs)
- Gender match
- Education match (± 4yrs)
- Normal macular exam
Who cannot join
- AMD
- Other significant eye pathology
- Mod/severe dementia
- Communication barrier that precludes testing
- Controls
- Other significant eye pathology
Show all 15Show fewer
- Mod/severe dementia
- Communication barrier that precludes testing
- MRI subset
- Devices or material incompatible with 3.0 Tesla MRI
- Conditions that may interfere with interpretation of fMRI (e.g. history of stroke, brain tumor or previous brain surgery; psychoactive medications; seizure disorder)
- Claustrophobia
- Left-handed
- Body weight > 300 lbs
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.
- Conditions
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMD controls | Not described | |
| AMD cases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
All Participants will receive neurocognitive testing, health and lifestyle surveys, audiometry and eye exams. Brain MRIs will be obtained on half the cohort, as this will provide sufficient power to accomplish the Aims that involve neuroimaging data. These MRIs will be obtained while participants are in the "resting state" meaning they are awake but not instructed to perform specific scanner. Two years after baseline exams, participants will return for repeat data collection. Participants who received an MRI at baseline will receive repeat resting-state, brain MRI at 2-year follow-up, unless they have developed contradictions to MRI scans in the interim.
Measured: Baseline, anticipated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Heather Whitson, MD, Principal investigator, Duke Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996215
- Sponsor's protocol ID
- Pro00046073
- Other IDs
- R01AG043438
- Status last verified
- Dec 2018
- First submitted
- 22 Nov 2013
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01996215
- Acronym / sponsor ID
- Pro00046073
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Nov 2013 (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.
This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD controls | – | – |
| AMD cases | – | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include 300 participants: 150 subjects with AMD plus 150 age, gender, and education-matched adults without AMD. All participants will receive baseline and 2 year neurocognitive tests and a subset will provide structural and "resting stage"functional magnetic resonance images (MRIs) at each time point.
Key inclusion criteria (7 listed)
- AMD
- Vision loss attributable to AMD
- Controls
- Age match (± 5 yrs)
- Gender match
Key exclusion criteria (15 listed)
- AMD
- Other significant eye pathology
- Mod/severe dementia
- Communication barrier that precludes testing
- Controls
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
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
Time frame: Baseline, anticipated 2 years
All Participants will receive neurocognitive testing, health and lifestyle surveys, audiometry and eye exams. Brain MRIs will be obtained on half the cohort, as this will provide sufficient power to accomplish the Aims that involve neuroimaging data. These MRIs will be obtained while participants are in the "resting state" meaning they are awake but not instructed to perform specific scanner. Two years after baseline exams, participants will return for repeat data collection. Participants who received an MRI at baseline will receive repeat resting-state, brain MRI at 2-year follow-up, unless they have developed contradictions to MRI scans in the interim.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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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.
Heather Whitson, MD principal investigator
Duke Medicine
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, run by Duke University 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 7 Feb 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration (time frame: Baseline, anticipated 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2019.