Eye to Brain Connection

Evaluation of Optina Retina Scans to Detect the Likeley Cerebral Amyloid Status (CAS) as Determined by Prospective PET Imaging

NCT05215782•Optina Diagnostics Inc.

View on ClinicalTrials.gov

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 referring physicians. Subjects may be participants from existing studies and clinical practices

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female adults aged 50 to 90 years (inclusive).
•2. 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.
•3. Demonstrated cognitive impairment as evidenced by at least one of the following:
•1. Mini Mental State Examination (MMSE) score \< 26/30
•2. Montreal Cognitive Assessment (MoCA) score \< 26/30
•3. 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 \[Based on guidelines for detecting Mild Cognitive Impairment due to AD (Albert et al., 2011)\]
•4. Cognitive impairment on the above test/s is unable to be fully explained by systemic, neurological or psychiatric disorders other than Alzheimer's disease.
•5. Capacity to give informed consent by patient or Legally Authorized Representative (LAR).
•6. Ability to undergo PET and MRI scans.

Exclusion Criteria

•1. 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)
+7 more criteria

Locations (1)

Ezy medical research

Miami, Florida, United States

Key Dates

Start Date

March 14, 2022

Primary Completion Date

March 16, 2023

Completion Date

March 16, 2023

Last Updated

March 24, 2023

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Eye to Brain Connection

Inclusion Criteria

Exclusion Criteria

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