Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test

NCT ID: NCT05107882

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 466 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2024-07-25

Brief Summary

This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC (K200254).

Detailed Description

This non-interventional, cross-sectional study is designed to validate a novel diagnostic test, the Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) test, for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (positive or negative). The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC for imaging the retina. The study objective is to characterize the performance of the diagnostic CAS test in the target population of adult patients fifty (50) years and older with cognitive impairment, who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. The data generated in this study will provide evidence to be used in the assessment of the benefits and risks associated with use of the device in the intended population. The primary endpoint is to demonstrate accuracy of the Optina Diagnostics' CAS test compared to amyloid-PET status, as determined by a majority of three (3) qualified, independent PET Readers.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Mild Dementia

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Male and female adults aged 50 years and older (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:

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 (in any domain), 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)]

• Clinical laboratory assessment (complete blood count [CBC], standard blood chemistry profile, thyroid stimulating hormone [TSH], vitamin B12) within the 6 months prior to enrollment.
• 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 substitute decision maker.
• Ability to undergo PET and MRI scans.

Exclusion Criteria

• Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC images by the CAS, including:

1. Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy)

2. Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the MHRC

3. Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7)

4. 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

5. 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)

6. Macular anomaly (e.g., macular hole, dystrophy, degeneration)

7. Nuclear sclerosis > 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract

8. Refractive error outside the range of -15 D to +15 D

9. Scar, atrophy, naevus, tumor, eepiretinal 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

10. Papilledema

11. Deficient visual fixation (inability to fixate for at least 2 s)

12. 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 imaging)

• Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation.
• Impossibility of obtaining a satisfactory quality amyloid-PET scan for interpretation by imaging specialists.
• Individuals who currently or have previously taken cerebral amyloid modifying medication.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

Optina Diagnostics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Okhravi, MD, PhD FRPC

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical Center

Richard Bergeron, PhD FRPC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Memory Clinic and Clinic Memoire Outaouais

Suman Jayadev, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Charles Bernick, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Lou Ruvo Center for Brain

Sandra Black, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute (SRI)

Jorge P. Bruno, MD

Role: PRINCIPAL_INVESTIGATOR

Ezy Medical Research

Giovanni J Marotta, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Centricity Research

Locations

Ezy Medical Research

Miami, Florida, United States

Lou Ruvo Center for Brain Health at Cleveland Clinic (LR-CC)

Las Vegas, Nevada, United States

East Virginia Medical School (EVMS)

Norfolk, Virginia, United States

University of Washington (MBWC)

Seattle, Washington, United States

Ottawa Memory Clinic (OMC)

Ottawa, Ontario, Canada

Centricity Research

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

DOC100464

Identifier Type: -

Identifier Source: org_study_id