Clinical trial NCT03699644: Multimodal Ocular Imaging in Neurodegeneration
Official title: Multimodal Ocular Imaging in Neurodegeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Alzheimer Dementia
Frontotemporal Dementia
Keywords: FTD
Dementia
Retina
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.


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).

Primary outcomes:
measure: Presence of Retinal Thinning
timeFrame: 45 minutes
Secondary outcomes:
measure: Presence of Amyloid Plaque
timeFrame: 45 Minutes
measure: Presence of Brain Pathology
timeFrame: 60 Minutes
measure: Presence of Brain Metabolism
timeFrame: 180 Minutes
measure: Presence of Macular Vascular Anomalies
timeFrame: 45 Minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cagri G. Besirli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: