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Alzheimer DiseaseREPHRASENCT05107882

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

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Optina Diagnostics Inc. at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
How many people
466 participants
Where
7 sitesin 2 countries
Study dates
7 Jun 2022to 25 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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)]
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  • 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.

Who cannot join

  • 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)
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  • 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.
  • Individuals who currently or have previously taken cerebral amyloid modifying medication.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

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

    Las Vegas, Nevada, 89106

  • Ezy Medical Research

    Miami, Florida, 33175

  • East Virginia Medical School (EVMS)

    Norfolk, Virginia, 23507

  • University of Washington (MBWC)

    Seattle, Washington, 98104

Other trials in United States

Canada3 sites

  • Ottawa Memory Clinic (OMC)

    Ottawa, Ontario, K1Z 1G3

  • Centricity Research

    Toronto, Ontario, M4G 3E8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Retinal Deep PhenotypingTM Platform for Cerebral Amyloid Status Evaluation: a Validation Study

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).

Read the 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.

Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2021
  2. Study start7 Jun 2022
  3. Primary completion25 Jul 2024
  4. Study completion25 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05107882
Sponsor's protocol ID
DOC100464
Acronym
REPHRASE
Status last verified
Aug 2024
First submitted
21 Oct 2021
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Optina Diagnostics Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinal beta-amyloid detection (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05107882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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