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

NCT05107882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 466

Last updated 2024-08-07

No results posted yet for this study

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

Sponsors & Collaborators

  • Eastern Virginia Medical School

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Sunnybrook Research Institute

    collaborator OTHER

  • Optina Diagnostics Inc.

    lead INDUSTRY

Principal Investigators

  • Hamid Okhravi, MD, PhD FRPC · Eastern Virginia Medical Center

  • Richard Bergeron, PhD FRPC · Ottawa Memory Clinic and Clinic Memoire Outaouais

  • Suman Jayadev, MD · University of Washington

  • Charles Bernick, MD, MPH · Cleveland Clinic Lou Ruvo Center for Brain

  • Sandra Black, MD · Sunnybrook Research Institute (SRI)

  • Jorge P. Bruno, MD · Ezy Medical Research

  • Giovanni J Marotta, MD, FRCP(C) · Centricity Research

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2024-07-25
Completion
2024-07-25

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107882 on ClinicalTrials.gov