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

NCT05107882 | Completed

• 1 other identifier: DOC100464
• Study Type: observational
• Target: 466
• Locations: 2 countries
• Sites: 7

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).

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Mild Dementia

Outcome Measures

Primary Outcomes (1)

• Retinal beta-amyloid detection

  Presence of absence of beta-amyloid plaques in the retina where the accuracy will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) with 95% confidence intervals.

  1 year

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population for the Optina Diagnostics' CAS test is men and women 50 years and older who are under clinical investigation for cognitive impairment where Alzheimer's disease (AD) is one of the possible differential diagnoses. As concomitant eye pathologies or conditions could interfere with CAS algorithm, individuals with certain ocular pathologies or conditions, including glaucoma, age-related macular degeneration (AMD), retinopathies, and advanced cataracts, will not be included in the target population at this time. Work is on-going to improve the CAS classifier algorithm with the goal to include these individuals in the target population at a later date.

You may qualify if:

• 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:
• 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 (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.

You may not qualify if:

• Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC images by the CAS, including:
• Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy)
• Inadequate pupil dilatation (\< 6mm diameter) preventing uniform illumination of the retina with the MHRC
• 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
• Refractive error outside the range of -15 D to +15 D
• 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
• Papilledema
• Deficient visual fixation (inability to fixate for at least 2 s)
• 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.

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead
• Eastern Virginia Medical School: collaborator
• The Cleveland Clinic: collaborator
• University of Washington: collaborator
• Sunnybrook Research Institute: collaborator

Study Sites (7)

Ezy Medical Research

Miami, Florida, 33175, United States

Location

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

Las Vegas, Nevada, 89106, United States

Location

East Virginia Medical School (EVMS)

Norfolk, Virginia, 23507, United States

Location

University of Washington (MBWC)

Seattle, Washington, 98104, United States

Location

Ottawa Memory Clinic (OMC)

Ottawa, Ontario, K1Z 1G3, Canada

Location

Centricity Research

Toronto, Ontario, M4G 3E8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Hamid Okhravi, MD, PhD FRPC

  Eastern Virginia Medical Center

  PRINCIPAL INVESTIGATOR

• Richard Bergeron, PhD FRPC

  Ottawa Memory Clinic and Clinic Memoire Outaouais

  PRINCIPAL INVESTIGATOR

• Suman Jayadev, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Charles Bernick, MD, MPH

  Cleveland Clinic Lou Ruvo Center for Brain

  PRINCIPAL INVESTIGATOR

• Sandra Black, MD

  Sunnybrook Research Institute (SRI)

  PRINCIPAL INVESTIGATOR

• Jorge P. Bruno, MD

  Ezy Medical Research

  PRINCIPAL INVESTIGATOR

• Giovanni J Marotta, MD, FRCP(C)

  Centricity Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 4, 2021
• Study Start: June 7, 2022
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (4)