Multimodal Ocular Imaging in Neurodegeneration
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 1/17/2019 |
| Start Date: | January 4, 2019 |
| End Date: | December 2020 |
| Contact: | Cagri G. Besirli, MD PhD |
| Email: | cbesirli@med.umich.edu |
| Phone: | (734) 615 - 2479 |
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.
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.
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).
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