Cognoa ASD Diagnosis Aid Validation Study

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Diagnostic Test: Cognoa ASD diagnostic device

• Registration Number: NCT04151290
• Lead Sponsor: Cognoa, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2019-08-07
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Primary Completion: 2020-06-05
• Study Completion: 2020-08-31
• Results First Submitted: 2021-06-18
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Results First Posted: 2021-12-28
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognoa Assessment	Cognoa ASD diagnostic device	Cognoa diagnostic ASD device.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation	6 Weeks	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:
No Result Percentage	6 Weeks	Measurement of the percentage of children for whom the device has provided no result.

Secondary Outcome Measures

Name	Time	Method
Device Sensitivity and Specificity	6 Weeks	Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.

Trial Locations

Locations (13)

Melmed Center; 🇺🇸 Scottsdale, Arizona, United States

ARC Clinical Research at Wilson Parke; 🇺🇸 Austin, Texas, United States

Orange County Child Neurology; 🇺🇸 Laguna Niguel, California, United States

Pediatric Neurology of Orange County; 🇺🇸 Laguna Niguel, California, United States

Private Practice; 🇺🇸 Seattle, Washington, United States

PriMed Clinical Research; 🇺🇸 Dayton, Ohio, United States

ARC Clinical Research William Cannon; 🇺🇸 Austin, Texas, United States

ARC Clinical Research Kelly Lane; 🇺🇸 Pflugerville, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Texas Child Neurology; 🇺🇸 Plano, Texas, United States

Multicare Health System - Mary Bridge Pediatrics; 🇺🇸 Tacoma, Washington, United States

The Nicholls Group; 🇺🇸 Scottsdale, Arizona, United States

MediSync Clinical Research Hattiesburg Clinic; 🇺🇸 Petal, Mississippi, United States