Cognoa ASD Diagnosis Aid Validation Study

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: Cognoa ASD diagnostic device

Detailed Description

To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

• Study Type: Interventional
• Enrollment (Actual): 711
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Melmed Center
    • Scottsdale, Arizona, United States, 85258
      • The Nicholls Group
  • California
    • Laguna Niguel, California, United States, 92677
      • Orange County Child Neurology
    • Laguna Niguel, California, United States, 92677
      • Pediatric Neurology of Orange County
    • Laguna Niguel, California, United States, 92677
      • Private Practice
    • Los Angeles, California, United States, 90034
      • Private Practice
    • Palo Alto, California, United States, 94303
      • Private Practice
  • Mississippi
    • Petal, Mississippi, United States, 39465
      • MediSync Clinical Research Hattiesburg Clinic
  • Ohio
    • Dayton, Ohio, United States, 45419
      • Primed Clinical Research
  • Texas
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Wilson Parke
    • Austin, Texas, United States, 78745
      • ARC Clinical Research William Cannon
    • Pflugerville, Texas, United States, 78660
      • ARC Clinical Research Kelly Lane
    • Plano, Texas, United States, 75024
      • Texas Child Neurology
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Seattle, Washington, United States, 98103
      • Private Practice
    • Tacoma, Washington, United States, 98405
      • Multicare Health System - Mary Bridge Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General Inclusion Criteria:

• Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
• Caregiver or HCP concern for developmental delay.
• Female or Male, >18 to <72 months of age

General Exclusion Criteria:

• Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
• Subjects whose age on the date of enrollment is outside the target age range.
• Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognoa Assessment; Cognoa diagnostic ASD device.	Diagnostic test: Cognoa ASD diagnostic device; Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation	Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:	6 Weeks
No Result Percentage	Measurement of the percentage of children for whom the device has provided no result.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Sensitivity and Specificity	Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.	6 Weeks

Collaborators and Investigators

• Sponsor: Cognoa, Inc.
• Investigators: Study Director: Sharief Taraman, MD, Cognoa, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: Q170886

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No