Eye to Brain Connection

NCT ID: NCT05215782

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2023-03-16

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

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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)
• 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

2. Inability of obtaining at least 3 images of satisfactory quality with the MHRC-C1 per the Optina Diagnostics quality index software.

3. Impossibility of obtaining a satisfactory quality amyloid-PET scan for interpretation by imaging specialists.

4. Individuals currently enrolled in cerebral amyloid modifying medication studies.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ezy Medical Research

UNKNOWN

Sponsor Role: collaborator

Optina Diagnostics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ezy medical research

Miami, Florida, United States

Countries

United States

Other Identifiers

DOC100681

Identifier Type: -

Identifier Source: org_study_id