Mild Cognitive ImpairmentNCT01937221
Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Mild to Moderate Cognitive Impairment, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild to Moderate Cognitive Impairment
- What is being tested?
- spectral-domain optical coherence tomography (SD-OCT)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal controls and patients with mild, mild to moderate cognitive impairment
Who may be able to join
- Result of the standard neuropsychological assessment
- Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years;
- Fluency in English
- Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance.
Who cannot join
- Known or suspected diagnosis of non-AD, associated dementia;
- Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).
- Being tested
- spectral-domain optical coherence tomography (SD-OCT)
- Keywords
- mild cognitive impairment, mild to moderate cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectral-domain optical coherence tomography (SD-OCT)Other
Intervention same to all groups.
| Study group | Role | What they receive |
|---|---|---|
| mild cognitive impairment | Not described Receives: Other: spectral-domain optical coherence tomography (SD-OCT) | |
| mild to moderate cognitive impairment | Not described Receives: Other: spectral-domain optical coherence tomography (SD-OCT) | |
| normal or control group | Not described Receives: Other: spectral-domain optical coherence tomography (SD-OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.
Measured: Baseline
NFL/GCL abnormality score
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have another measurement taken at 12 months.
Measured: 12 months
Secondary outcomes (4)
Drusen/plaque score
The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subject groups at baseline.
Measured: Baseline
Drusen/plaque score
The study will determine the significance of difference in peripheral drusen/amyloid plaque score between the AD subjects groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement at 12 months.
Measured: 12 months
Total drusen area
The study will determine the significance of difference in total drusen area between the AD subject groups at baseline.
Measured: Baseline
Total drusen area
The study will determine the significance of difference in total drusen area between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have a second measurement taken at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Institute for Brain Sciences, Alzheimer's Association, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Heather Whitson, MD, MHS, Principal investigator, Duke UniversityEleonora Lad, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937221
- Sponsor's protocol ID
- Pro00047227
- Status last verified
- Dec 2017
- First submitted
- 4 Sep 2013
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01937221
- Acronym / sponsor ID
- Pro00047227
- Keywords
- mild cognitive impairment, mild to moderate cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Institute for Brain Sciences, Alzheimer's Association, Duke-NUS Graduate Medical School
- Study start
- Sep 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Sep 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.
The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild cognitive impairment | – | Other: spectral-domain optical coherence tomography (SD-OCT) |
| mild to moderate cognitive impairment | – | Other: spectral-domain optical coherence tomography (SD-OCT) |
| normal or control group | – | Other: spectral-domain optical coherence tomography (SD-OCT) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal controls and patients with mild, mild to moderate cognitive impairment
Key inclusion criteria (4 listed)
- Result of the standard neuropsychological assessment
- Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years;
- Fluency in English
- Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance.
Key exclusion criteria (2 listed)
- Known or suspected diagnosis of non-AD, associated dementia;
- Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectral-domain optical coherence tomography (SD-OCT)Intervention same to all groups. | Other | mild cognitive impairment, mild to moderate cognitive impairment, normal or control group |
Primary outcome
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
Time frame: Baseline
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.
NFL/GCL abnormality score
Time frame: 12 months
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have another measurement taken at 12 months.
4 secondary outcomes
Drusen/plaque score
Time frame: Baseline
Drusen/plaque score
Time frame: 12 months
Total drusen area
Time frame: Baseline
Total drusen area
Time frame: 12 months
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 31 Jan 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, MHS principal investigator
Duke University
Eleonora Lad, MD, PhD principal investigator
Duke University
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 Mild Cognitive Impairment and Mild to Moderate Cognitive Impairment, 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 4 inclusion and 2 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 31 Jan 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?
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score (time frame: Baseline). The study lists 2 primary outcomes in all. 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 31 Jan 2019.