Alzheimer DiseaseNCT03699644
Multimodal Ocular Imaging in Neurodegeneration
An observational study of Alzheimer Disease and Alzheimer Dementia, run by University of Michigan at 1 site in United States.
Trial summary
Alzheimer's disease (AD) and frontotemporal dementia (FTD) are two of the most common types of age-related neurodegenerative disorders. Identifying at-risk patients and gauging disease progression in a non-invasive manner would be invaluable. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Alzheimer Dementia, Frontotemporal Dementia
- What is being tested?
- Spectral-Domain Optical Coherence Tomography (SD-OCT), Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET)
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 3 Apr 2019
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited with mid-to-late stage AD and FTD, as well as age-matched healthy controls, using the extensive database of research participants maintained by the Michigan Alzheimer's Disease Center (MADC).
Who may be able to join
- Subjects with dementia must have known diagnosis of Alzheimer's dementia (AD) or frontotemporal dementia (FTD)
- Subjects with dementia must have Moderate/severe dementia as preferentially defined by a documented MoCA score of less than 17, or by MMSE score of less than 17, within the last 12 months
- Individuals with no evidence of AD or FTD as age-matched controls.
Who cannot join
- Preexisting retinal or optic nerve disorder including macular degeneration, diabetic retinopathy, retinal dystrophy, and glaucoma
- Anterior segment abnormalities of the eye limiting ocular imaging (e.g. corneal disorders, dense cataract).
- Use of medications with known effects on the retina or optic nerve (e.g. hydroxychloroquine, ethambutol).
- Pregnant or lactating women.
- Prisoners.
- Subjects with advanced dementia who cannot be independently and reliably positioned at the ocular imaging device for reliable imaging.
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- Subjects with contraindications to magnetic resonance (MR) imaging, including pacemakers or claustrophobia.
- Evidence of large vessel stroke or mass lesion identified on MR imaging.
- Subjects limited by participation in research procedures involving ionizing radiation.
- Subjects who are already participating in another clinical study or clinical trial
- Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of any of the investigators, might preclude safe completion of the study or might affect the results of the study. These include conditions causing significant central nervous system or autonomic dysfunction, such as congestive heart failure, recent (<6 months) myocardial infarction, thrombocytopenia (<50 x 10(9)/L), immunosuppressed state, severe uncontrolled hypertension, severe cardiopulmonary disease, severe anemia (hemoglobin <8g/dl), severe liver or kidney disease (creatinine >2.3 mg/dl) uncontrolled diabetes mellitus (HgbA1c >10g%), alcoholism, malignant neoplasms, amyloidosis, uncontrolled hypothyroidism, unstable peripheral neuropathies, concurrent infections, orthopedic problems that compromise mobility and activities of daily living, severe cerebrovascular accidents (causing symptoms such as hemiplegia, aphasia and non-dominant parietal lobe syndrome), history of exposure to neurotoxins or neuroactive drugs, or parkinsonism due to drugs (including neuroleptics, alpha-methyldopa, reserpine, metoclopramide).
Trial locations and contacts
1 site in 1 country.
About this study
Alzheimer's disease (AD) and frontotemporal dementia (FTD) are two of the most common types of age-related neurodegenerative disorders. Identifying at-risk patients and gauging disease progression in a non-invasive manner would be invaluable. Early and correct diagnosis is crucial for coordinating supportive care, patient expectations, caregiver arrangements and family planning. In addition, as treatments become available, beginning therapy early in the disease before symptoms become severe will be important. Multimodal ocular imaging (MOI) includes an ophthalmic (eye) exam and eye photographs to evaluate different layers of the retina, which is the light sensing layer of the eye. Newer technologies make it possible to visualize the disease process occurring in AD and FTD by using MOI to look at the retina, since the retina is fundamentally an outward extension of the brain itself. This study will attempt to correlate signs of disease in the retina, as determined by MOI, with plaque buildup in the brain as seen by imaging. This will demonstrate the sensitivity and specificity of MOI for diagnosing AD and FTD in a noninvasive manner.
- Being tested
- Spectral-Domain Optical Coherence Tomography (SD-OCT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), Comprehensive Ophthalmic Examination, Fundus Photography
- Keywords
- FTD, Dementia, Retina
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia, Dementia
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)Device
Also called Imaging of the Eye
Each participant in this study will undergo Optical coherence tomography (OCT), a non-invasive imaging test of the eye, one time. OCT uses light waves to take cross-section pictures of the retina, which are generated using scattered light waves.
Magnetic Resonance Imaging (MRI)Device
Each participant in this study will undergo a single Magnetic resonance imaging (MRI) scan, a scanning technique for creating detailed images of the human body. The scan uses a magnetic field and radio waves to generate images of the brain.
Positron Emission Tomography (PET)Device
Each participant in this study will undergo a single Positron emission tomography (PET) scan of the brain. PET is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the brain as an aid to the diagnosis of disease using the combination of a radioactive tracer, camera, and a computer.
Comprehensive Ophthalmic ExaminationDiagnostic test
Also called Comprehensive Eye Examination
Each participant in this study will receive one comprehensive eye examination which will be performed by a licensed ophthalmologist at the University of Michigan. This examination will include the assessment of the participant's visual acuity, a slit lamp examination which will look at the anterior and posterior tissues of the eye including the retina using various lights and lenses, and intraocular pressures.
Fundus PhotographyDevice
Also called Photography of the Eye
Each participant in this study will undergo fundus photography of each eye. Fundus photography involves the use of a retinal camera coupled with a low power microscope to capture photographs of the retina.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy controls will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, all healthy controls will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. Receives: Device: Spectral-Domain Optical Coherence Tomography (SD-OCT); Device: Magnetic Resonance Imaging (MRI); Device: Positron Emission Tomography (PET); Diagnostic Test: Comprehensive Ophthalmic Examination; Device: Fundus Photography | |
| Alzheimer's Dementia | Subjects with Alzheimer's Dementia will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, all subjects with Alzheimer's Dementia will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. Receives: Device: Spectral-Domain Optical Coherence Tomography (SD-OCT); Device: Magnetic Resonance Imaging (MRI); Device: Positron Emission Tomography (PET); Diagnostic Test: Comprehensive Ophthalmic Examination; Device: Fundus Photography | |
| Frontotemporal Dementia | Subjects with Frontotemporal Dementia will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, subjects with Frontotemporal Dementia will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. Receives: Device: Spectral-Domain Optical Coherence Tomography (SD-OCT); Device: Magnetic Resonance Imaging (MRI); Device: Positron Emission Tomography (PET); Diagnostic Test: Comprehensive Ophthalmic Examination; Device: Fundus Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Retinal Thinning
Imaging of the eye will be used to measure differences in retinal thickness between subjects with Alzheimer's Dementia, Frontotemporal Dementia, and healthy age-matched controls.
Measured: 45 minutes
Secondary outcomes (4)
Presence of Amyloid Plaque
Fundus autofluorescence (FAF) will be used to detect the presence of lipofuscin
Measured: 45 Minutes
Presence of Brain Pathology
MRI of the brain will be performed in order to determine if pathology observed on neuroimaging correlates quantitatively and/or qualitatively with retinal thickness.
Measured: 60 Minutes
Presence of Brain Metabolism
PET scanning of the brain will be performed in order to determine if brain metabolism observed on neuroimaging correlates quantitatively and/or qualitatively with retinal thickness.
Measured: 180 Minutes
Presence of Macular Vascular Anomalies
Imaging of the eye will be used to measure differences in vascular density between subjects with Alzheimer's Dementia, Frontotemporal Dementia, and healthy age-matched controls.
Measured: 45 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start4 Jan 2019
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagri Besirli, University of Michigan
- Investigators
- Cagri G. Besirli, MD PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699644
- Sponsor's protocol ID
- HUM00146956
- Status last verified
- Mar 2022
- First submitted
- 5 Oct 2018
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD Data may be shared if requests to the PI are made, a reasonable plan is proposed, and Data Use agreements are put in place.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Ocular Imaging in Neurodegeneration
- ClinicalTrials.gov ID
- NCT03699644
- Acronym / sponsor ID
- HUM00146956
- Keywords
- FTD, Dementia, Retina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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.
Alzheimer's disease (AD) and frontotemporal dementia (FTD) are two of the most common types of age-related neurodegenerative disorders. Identifying at-risk patients and gauging disease progression in a non-invasive manner would be invaluable. Early and correct diagnosis is crucial for coordinating supportive care, patient expectations, caregiver arrangements and family planning. In addition, as treatments become available, beginning therapy early in the disease before symptoms become severe will be important. Multimodal ocular imaging (MOI) includes an ophthalmic (eye) exam and eye photographs to evaluate different layers of the retina, which is the light sensing layer of the eye. Newer technologies make it possible to visualize the disease process occurring in AD and FTD by using MOI to look at the retina, since the retina is fundamentally an outward extension of the brain itself. This study will attempt to correlate signs of disease in the retina, as determined by MOI, with plaque buildup in the brain as seen by imaging. This will demonstrate the sensitivity and specificity of MOI for diagnosing AD and FTD in a noninvasive manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: Spectral-Domain Optical Coherence Tomography (SD-OCT), Device: Magnetic Resonance Imaging (MRI), Device: Positron Emission Tomography (PET), Diagnostic Test: Comprehensive Ophthalmic Examination, Device: Fundus PhotographyHealthy controls will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, all healthy controls will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. |
| Alzheimer's Dementia | – | Device: Spectral-Domain Optical Coherence Tomography (SD-OCT), Device: Magnetic Resonance Imaging (MRI), Device: Positron Emission Tomography (PET), Diagnostic Test: Comprehensive Ophthalmic Examination, Device: Fundus PhotographySubjects with Alzheimer's Dementia will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, all subjects with Alzheimer's Dementia will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. |
| Frontotemporal Dementia | – | Device: Spectral-Domain Optical Coherence Tomography (SD-OCT), Device: Magnetic Resonance Imaging (MRI), Device: Positron Emission Tomography (PET), Diagnostic Test: Comprehensive Ophthalmic Examination, Device: Fundus PhotographySubjects with Frontotemporal Dementia will undergo a single magnetic resonance imaging (MRI) and PET (positron emission tomography) scan of the brain. In addition, subjects with Frontotemporal Dementia will receive a comprehensive ophthalmic examination as well as undergo photography and imaging of the eye. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited with mid-to-late stage AD and FTD, as well as age-matched healthy controls, using the extensive database of research participants maintained by the Michigan Alzheimer's Disease Center (MADC).
Key inclusion criteria (3 listed)
- Subjects with dementia must have known diagnosis of Alzheimer's dementia (AD) or frontotemporal dementia (FTD)
- Subjects with dementia must have Moderate/severe dementia as preferentially defined by a documented MoCA score of less than 17, or by MMSE score of less than 17, within the last 12 months
- Individuals with no evidence of AD or FTD as age-matched controls.
Key exclusion criteria (11 listed)
- Preexisting retinal or optic nerve disorder including macular degeneration, diabetic retinopathy, retinal dystrophy, and glaucoma
- Anterior segment abnormalities of the eye limiting ocular imaging (e.g. corneal disorders, dense cataract).
- Use of medications with known effects on the retina or optic nerve (e.g. hydroxychloroquine, ethambutol).
- Pregnant or lactating women.
- Prisoners.
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)Also: Imaging of the EyeEach participant in this study will undergo Optical coherence tomography (OCT), a non-invasive imaging test of the eye, one time. OCT uses light waves to take cross-section pictures of the retina, which are generated using scattered light waves. | Device | Alzheimer's Dementia, Frontotemporal Dementia, Healthy Control |
| Magnetic Resonance Imaging (MRI)Each participant in this study will undergo a single Magnetic resonance imaging (MRI) scan, a scanning technique for creating detailed images of the human body. The scan uses a magnetic field and radio waves to generate images of the brain. | Device | Alzheimer's Dementia, Frontotemporal Dementia, Healthy Control |
| Positron Emission Tomography (PET)Each participant in this study will undergo a single Positron emission tomography (PET) scan of the brain. PET is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the brain as an aid to the diagnosis of disease using the combination of a radioactive tracer, camera, and a computer. | Device | Alzheimer's Dementia, Frontotemporal Dementia, Healthy Control |
| Comprehensive Ophthalmic ExaminationAlso: Comprehensive Eye ExaminationEach participant in this study will receive one comprehensive eye examination which will be performed by a licensed ophthalmologist at the University of Michigan. This examination will include the assessment of the participant's visual acuity, a slit lamp examination which will look at the anterior and posterior tissues of the eye including the retina using various lights and lenses, and intraocular pressures. | Diagnostic test | Alzheimer's Dementia, Frontotemporal Dementia, Healthy Control |
| Fundus PhotographyAlso: Photography of the EyeEach participant in this study will undergo fundus photography of each eye. Fundus photography involves the use of a retinal camera coupled with a low power microscope to capture photographs of the retina. | Device | Alzheimer's Dementia, Frontotemporal Dementia, Healthy Control |
Primary outcome
Presence of Retinal Thinning
Time frame: 45 minutes
Imaging of the eye will be used to measure differences in retinal thickness between subjects with Alzheimer's Dementia, Frontotemporal Dementia, and healthy age-matched controls.
4 secondary outcomes
Presence of Amyloid Plaque
Time frame: 45 Minutes
Presence of Brain Pathology
Time frame: 60 Minutes
Presence of Brain Metabolism
Time frame: 180 Minutes
Presence of Macular Vascular Anomalies
Time frame: 45 Minutes
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 28 Mar 2022.
- Individual participant dataSharing planned: Yes. IPD Data may be shared if requests to the PI are made, a reasonable plan is proposed, and Data Use agreements are put in place.
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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.
Cagri G. Besirli, MD PhD principal investigator
University of Michigan
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 Alzheimer Disease and Alzheimer Dementia, run by University of Michigan 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 3 inclusion and 11 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 28 Mar 2022. 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?
Presence of Retinal Thinning (time frame: 45 minutes). 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 28 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.