Multimodal Ocular Imaging in Neurodegeneration

NCT ID: NCT03699644

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-04-03

Brief 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. 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.

Conditions

Alzheimer Disease; Alzheimer Dementia; Frontotemporal Dementia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Spectral-Domain Optical Coherence Tomography (SD-OCT)

Intervention Type: DEVICE

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)

Intervention Type: 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)

Intervention Type: 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 Examination

Intervention Type: DIAGNOSTIC_TEST

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 Photography

Intervention Type: DEVICE

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.

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.

Spectral-Domain Optical Coherence Tomography (SD-OCT)

Intervention Type: DEVICE

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)

Intervention Type: 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)

Intervention Type: 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 Examination

Intervention Type: DIAGNOSTIC_TEST

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 Photography

Intervention Type: DEVICE

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.

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.

Spectral-Domain Optical Coherence Tomography (SD-OCT)

Intervention Type: DEVICE

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)

Intervention Type: 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)

Intervention Type: 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 Examination

Intervention Type: DIAGNOSTIC_TEST

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 Photography

Intervention Type: DEVICE

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.

Interventions

Spectral-Domain Optical Coherence Tomography (SD-OCT)

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Comprehensive Ophthalmic 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.

Intervention Type: DIAGNOSTIC_TEST

Fundus Photography

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.

Intervention Type: DEVICE

Other Intervention Names

Imaging of the Eye; Comprehensive Eye Examination; Photography of the Eye

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Cagri Besirli

Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cagri G. Besirli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00146956

Identifier Type: -

Identifier Source: org_study_id