Multimodal Ocular Imaging in Neurodegeneration

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University of Michigan

Status

Completed

Conditions

Alzheimer Dementia
Alzheimer Disease
Frontotemporal Dementia

Treatments

Device: Positron Emission Tomography (PET)
Device: Spectral-Domain Optical Coherence Tomography (SD-OCT)
Device: Magnetic Resonance Imaging (MRI)
Device: Fundus Photography
Diagnostic Test: Comprehensive Ophthalmic Examination

Study type

Observational

Funder types

Other

Identifiers

NCT03699644
HUM00146956

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

45 to 80 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

16 participants in 3 patient groups

Healthy Control
Description:
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.
Treatment:
Diagnostic Test: Comprehensive Ophthalmic Examination
Device: Fundus Photography
Device: Magnetic Resonance Imaging (MRI)
Device: Spectral-Domain Optical Coherence Tomography (SD-OCT)
Device: Positron Emission Tomography (PET)
Alzheimer's Dementia
Description:
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.
Treatment:
Diagnostic Test: Comprehensive Ophthalmic Examination
Device: Fundus Photography
Device: Magnetic Resonance Imaging (MRI)
Device: Spectral-Domain Optical Coherence Tomography (SD-OCT)
Device: Positron Emission Tomography (PET)
Frontotemporal Dementia
Description:
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.
Treatment:
Diagnostic Test: Comprehensive Ophthalmic Examination
Device: Fundus Photography
Device: Magnetic Resonance Imaging (MRI)
Device: Spectral-Domain Optical Coherence Tomography (SD-OCT)
Device: Positron Emission Tomography (PET)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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