Status:
COMPLETED
Eye to Brain Connection
Lead Sponsor:
Optina Diagnostics Inc.
Collaborating Sponsors:
Ezy Medical Research
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-90 years
Brief Summary
This is a non-randomized, non-treatment, observational study designed to discover correlations between retinal imaging and amyloid PET imaging. Subjects will be recruited to the clinical cohort from r...
Eligibility Criteria
Inclusion
- Male and female adults aged 50 to 90 years (inclusive).
- Individuals with reported cognitive complaint (self or from an informant) under clinical investigation by a health professional for cognitive impairment where Alzheimer's disease (AD) is one of the differential diagnoses.
- Demonstrated cognitive impairment as evidenced by at least one of the following:
- Mini Mental State Examination (MMSE) score \< 26/30
- Montreal Cognitive Assessment (MoCA) score \< 26/30
- Score \> 1 Standard Deviation below population mean on a standardized neuropsychological test, based on normative data from age-, sex-, education-, and where possible, race-matched peers \[Based on guidelines for detecting Mild Cognitive Impairment due to AD (Albert et al., 2011)\]
- Cognitive impairment on the above test/s is unable to be fully explained by systemic, neurological or psychiatric disorders other than Alzheimer's disease.
- Capacity to give informed consent by patient or Legally Authorized Representative (LAR).
- Ability to undergo PET and MRI scans.
Exclusion
- Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC-C1 images by the CAS, including:
- Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick frading of 0 or 1 without iridotomy)
- Inadequate pupil dilatation (\< 6mm diameter) preventing uniform illumination of the retina with the MHRC-C1
- Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7)
- Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula
- Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale
- 4 - cumulative drusen area diameter ≥ 250 um, pigmentary changes and cumulative drusen area diameter ≥ 63 um or pigmentary changes and cumulative geographic atrophy area diameter ≥ 354 um)
- Macular anomaly (e.g. macular hole, dystrophy, degeneration)
- Nuclear sclerosis \> 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract
- Deficient visual fixation (inability to fixate for at least 2 s)
- Refractive error outside the range of -15 D to +15 D
- Corneal or media opacities (e.g. Weiss ring) affecting retinal imaging on a cumulative area \> 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula (i.e. the area of interest for the MHRC-C1 imaging)
- Scar, atrophy, naevus, tumor, epiretinal membrane or retinal pucker with a cumulative area \> 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula
- Papilledema
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC-C1 per the Optina Diagnostics quality index software.
- Impossibility of obtaining a satisfactory quality amyloid-PET scan for interpretation by imaging specialists.
- Individuals currently enrolled in cerebral amyloid modifying medication studies.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05215782
Start Date
March 14 2022
End Date
March 16 2023
Last Update
March 24 2023
Active Locations (1)
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1
Ezy medical research
Miami, Florida, United States, 33175