Eye to Brain Connection

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215782
• Other study ID #: DOC100681
• Status: Completed
• Start date: March 14, 2022
• Est. completion date: March 16, 2023

Study information

• Verified date: March 2023
• Source: Optina Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	Ezy medical research	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Optina Diagnostics Inc.	Ezy Medical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify features in the retinal hyperspectral images that strongly correlate with the cerebral Aß plaque status (positive or negative) measured with amyloid PET imaging.		1 year
Secondary	Evaluate the classification performance of the Optina software to detect the likely cerebral amyloid status.		1 year